Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of Adding Enfuvirtide to Oral Highly Active Antiretroviral Therapy (HAART) in Human Immunodeficiency Virus (HIV) Patients With Prior Treatment Experience (NCT NCT00487188)

NCT ID: NCT00487188

Last Updated: 2015-08-13

Results Overview

Participants whose viral load achieved suppression (HIV-1 RNA \< 50 copies/mL) at Week 24 at the latest, confirmed at Week 28 (2 consecutive assessments ≥ 28 days apart) were defined as responders. Patients who discontinued the study or did not respond to assigned treatment by week 28 were considered as non-responders.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 47 participants
• Primary outcome timeframe: From Baseline 1 to Week 28
• Results posted on: 2015-08-13

Participant Flow

A total of 47 patients were enrolled into the study at 20 investigational sites in France, Italy, Spain, Mexico, Germany and the US. Study starting 15NOV2005 and ending 5NOV2007.

In the Induction Phase participants were randomized (2:1 ratio) to receive ENF + HAART or HAART. In the Maintenance Phase participants in the HAART group who responded (viral load < 50 copies/mL) continued to receive HAART; those who responded in the ENF + HAART group were re-randomized (1:1 ratio) to receive ENF + HAART or HAART (ENF removed).

Participant milestones

Measure	ENF + HAART Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment during the Induction and Maintenance Phase for up to 48 weeks of treatment.	HAART Participants received highly active antiretroviral treatment during the Induction and Maintenance Phase for up to 48 weeks of treatment.	HAART (ENF Removed) Participants who had received ENF + HAART during the Induction Phase and responded to treatment by Week 24 continued to receive HAART alone during the Maintenance Phase, for a total of 48 weeks of treatment.
Induction Phase STARTED	31	16	0
Induction Phase Safety Population	29	18	0
Induction Phase COMPLETED	22	9	0
Induction Phase NOT COMPLETED	9	7	0
Maintenance Phase STARTED	10	8	9
Maintenance Phase COMPLETED	7	8	8
Maintenance Phase NOT COMPLETED	3	0	1

Reasons for withdrawal

Measure	ENF + HAART Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment during the Induction and Maintenance Phase for up to 48 weeks of treatment.	HAART Participants received highly active antiretroviral treatment during the Induction and Maintenance Phase for up to 48 weeks of treatment.	HAART (ENF Removed) Participants who had received ENF + HAART during the Induction Phase and responded to treatment by Week 24 continued to receive HAART alone during the Maintenance Phase, for a total of 48 weeks of treatment.
Induction Phase Abnormality of Laboratory Test	0	1	0
Induction Phase Adverse Event	5	0	0
Induction Phase Lack of Efficacy	0	1	0
Induction Phase Protocol Violation	1	0	0
Induction Phase Refused Treatment	1	2	0
Induction Phase Lost to Follow-up	2	2	0
Induction Phase Administrative	0	1	0
Maintenance Phase Adverse Event	1	0	0
Maintenance Phase Death	1	0	0
Maintenance Phase Lost to Follow-up	1	0	0
Maintenance Phase Administrative	0	0	1

Baseline Characteristics

A Study to Evaluate the Safety and Efficacy of Adding Enfuvirtide to Oral Highly Active Antiretroviral Therapy (HAART) in Human Immunodeficiency Virus (HIV) Patients With Prior Treatment Experience

Baseline characteristics by cohort

Measure	ENF+HAART n=29 Participants Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.	HAART n=18 Participants Participants received highly active antiretroviral treatment.	Total n=47 Participants Total of all reporting groups
Age, Continuous	44.1 years STANDARD_DEVIATION 7.04 • n=5 Participants	41.9 years STANDARD_DEVIATION 10.57 • n=7 Participants	43.3 years STANDARD_DEVIATION 8.52 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	15 Participants n=7 Participants	37 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Baseline 1 to Week 28

Population: Intent-to-Treat Population 1 (ITT1) population (patients evaluable for efficacy in the induction phase)

Participants whose viral load achieved suppression (HIV-1 RNA < 50 copies/mL) at Week 24 at the latest, confirmed at Week 28 (2 consecutive assessments ≥ 28 days apart) were defined as responders. Patients who discontinued the study or did not respond to assigned treatment by week 28 were considered as non-responders.

Outcome measures

Measure	ENF+HAART n=31 Participants Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.	HAART n=16 Participants Participants received highly active antiretroviral treatment.	HAART (ENF Removed) Participants who had received ENF + HAART during the Induction Phase and responded to treatment by Week 24 continued to receive HAART alone during the Maintenance Phase, for a total of 48 weeks of treatment.
Number of Participants With Viral Suppression: HIV-1 RNA < 50 Copies/mL During the Induction Phase	20 Participants	8 Participants	—

SECONDARY outcome

Timeframe: Baseline 1 until Week 28.

Population: Intent-to-Treat Population 1 (ITT1) population (patients evaluable for efficacy in the induction phase).

The time to achieving HIV-1 RNA <50 copies/mL was counted from Baseline 1 until the first of the two consecutive <50 copies/mL measurements.

Patients who discontinued from the study or patients who did not have confirmed virological response by week 28 were classed as non-responders and censored at Week 24.

Outcome measures

Measure	ENF+HAART n=31 Participants Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.	HAART n=16 Participants Participants received highly active antiretroviral treatment.	HAART (ENF Removed) Participants who had received ENF + HAART during the Induction Phase and responded to treatment by Week 24 continued to receive HAART alone during the Maintenance Phase, for a total of 48 weeks of treatment.
Time to Achieving HIV-1 RNA < 50 Copies/mL During the Induction Phase	57.0 days Interval 29.0 to 119.0	141.0 days Interval 70.0 to The 75% quartile could not be calculated as \>75% of patients did not achieve HIV-1 RNA \< 50 Copies/mL in this arm.	—

SECONDARY outcome

Timeframe: From Baseline 1 to Week 28

Population: ITT1 population (patients evaluable for efficacy in the induction phase)

Participants whose viral load achieved suppression (HIV-1 RNA < 400 copies/mL) by Week 24 at the latest, confirmed at Week 28 (2 consecutive assessments ≥ 28 days apart) were defined as responders. Patients who discontinued the study or did not respond to assigned treatment by Week 28 were considered as non-responders.

Outcome measures

Measure	ENF+HAART n=31 Participants Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.	HAART n=16 Participants Participants received highly active antiretroviral treatment.	HAART (ENF Removed) Participants who had received ENF + HAART during the Induction Phase and responded to treatment by Week 24 continued to receive HAART alone during the Maintenance Phase, for a total of 48 weeks of treatment.
Number of Participants With Viral Suppression HIV-1 RNA < 400 Copies/mL During the Induction Phase	21 Participants	8 Participants	—

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Intent-to-Treat Population 1 (ITT1) population (patients evaluable for efficacy in the Induction Phase). Baseline values were carried forward (i.e. the change from baseline set to zero) for patients with missing data at week 24 or who withdrew prior to the week 24 time window.

Change from Baseline in log10 HIV-1 RNA at Week 24. Least squares means were calculated from an analysis of covariance (ANCOVA) model with treatment, a flag variable "removed ENF at re-randomization" and Baseline viral load as independent variables.

Outcome measures

Measure	ENF+HAART n=31 Participants Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.	HAART n=16 Participants Participants received highly active antiretroviral treatment.	HAART (ENF Removed) Participants who had received ENF + HAART during the Induction Phase and responded to treatment by Week 24 continued to receive HAART alone during the Maintenance Phase, for a total of 48 weeks of treatment.
Change From Baseline to Week 24 in Viral Load	-1.402 log10 copies/mL 95% Confidence Interval 0.69 • Interval -1.854 to -0.949	-1.156 log10 copies/mL 95% Confidence Interval 0.61 • Interval -1.71 to -0.601	—

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Intent-to-Treat Population 1 (ITT1) population (patients evaluable for efficacy in the Induction Phase). Baseline values were carried forward (i.e. the change from baseline set to zero) for patients with missing data at week 24 or who withdrew prior to the week 24 time window.

Change from Baseline in CD4+ Cell Counts at Week 24. Least squares means were calculated from an ANCOVA model with treatment as an independent variable.

Outcome measures

Measure	ENF+HAART n=31 Participants Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.	HAART n=16 Participants Participants received highly active antiretroviral treatment.	HAART (ENF Removed) Participants who had received ENF + HAART during the Induction Phase and responded to treatment by Week 24 continued to receive HAART alone during the Maintenance Phase, for a total of 48 weeks of treatment.
Change From Baseline to Week 24 in Cluster Differentiation Antigen Four Positive (CD4+) Cell Counts	20.81 cells/mm^3 Interval -18.89 to 60.5	17.88 cells/mm^3 Interval -37.38 to 73.13	—

SECONDARY outcome

Timeframe: Week 48

Population: Induction Phase Intent-to-Treat Population 1 (ITT1).

The percentage of participants from the Induction Phase who maintained HIV-1 RNA < 50 Copies/mL at Week 48. Patients who discontinued from the study, rebounded to ≥ 50 copies/mL (i.e., had two consecutive readings ≥ 50 copies/mL), had missing data or had virological failure by Week 48 were classed as non-responders.

Outcome measures

Measure	ENF+HAART n=31 Participants Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.	HAART n=16 Participants Participants received highly active antiretroviral treatment.	HAART (ENF Removed) Participants who had received ENF + HAART during the Induction Phase and responded to treatment by Week 24 continued to receive HAART alone during the Maintenance Phase, for a total of 48 weeks of treatment.
Percentage of Induction Phase Participants With Viral Load < 50 Copies/mL at 48 Weeks	45.2 percentage of participants	25.0 percentage of participants	—

SECONDARY outcome

Timeframe: Week 48

Population: Maintenance Phase Intent-to-Treat Population 2 (ITT2).

The percentage of participants from the Maintenance Phase who maintained HIV-1 RNA < 50 copies/mL at Week 48. Patients who discontinued from the study, rebounded to ≥ 50 copies/mL (i.e., had two consecutive readings ≥ 50 copies/mL), had missing data or had virological failure by Week 48 were classed as non-responders.

Outcome measures

Measure	ENF+HAART n=19 Participants Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.	HAART n=8 Participants Participants received highly active antiretroviral treatment.	HAART (ENF Removed) Participants who had received ENF + HAART during the Induction Phase and responded to treatment by Week 24 continued to receive HAART alone during the Maintenance Phase, for a total of 48 weeks of treatment.
Percentage of Maintenance Phase Participants With Viral Load < 50 Copies/mL at 48 Weeks	73.7 percentage of participants	50.0 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline 1 and Week 48

Population: Intent-to-Treat Population 2 (ITT2) population (patients evaluable for efficacy in the Maintenance Phase). Baseline values were carried forward (i.e. the change from baseline set to zero) for patients with missing data at week 48 or who withdrew prior to the week 48 time window.

Change from Baseline in CD4 Cell Counts at Week 48. Least squares means were calculated from an ANCOVA model with treatment and baseline CD4 count as independent variables.

Outcome measures

Measure	ENF+HAART n=19 Participants Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.	HAART n=8 Participants Participants received highly active antiretroviral treatment.	HAART (ENF Removed) Participants who had received ENF + HAART during the Induction Phase and responded to treatment by Week 24 continued to receive HAART alone during the Maintenance Phase, for a total of 48 weeks of treatment.
Change From Baseline to Week 48 in Cluster Differentiation Antigen Four Positive (CD4) Cell Counts	73.09 cells/mm^3 Interval -4.1 to 150.28	50.79 cells/mm^3 Interval -68.24 to 169.83	—

SECONDARY outcome

Timeframe: From Baseline 2 to Week 48.

Population: Maintenance Phase Intent-to-Treat Population 2 (ITT2)

The time to loss of viral response (defined as HIV-1 RNA <50 copies/mL) was counted from Baseline 2 until the first of two consecutive ≥50 copies/mL measurements.

Only patients who were qualified for entering the Maintenance Phase were included in the analysis.

Outcome measures

Measure	ENF+HAART n=19 Participants Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.	HAART n=8 Participants Participants received highly active antiretroviral treatment.	HAART (ENF Removed) Participants who had received ENF + HAART during the Induction Phase and responded to treatment by Week 24 continued to receive HAART alone during the Maintenance Phase, for a total of 48 weeks of treatment.
Time to Loss of Viral Response During the Maintenance Phase	NA days Median time to loss of viral response could not be estimated due to the low number of patients with loss of viral response in this arm (4 out of 19 ITT2 patients) and the inter-quartile range was not calculated.	NA days Median time to loss of viral response could not be estimated due to the low number of patients with loss of viral response in this arm (3 out of 8 ITT2 patients) and the inter-quartile range was not calculated.	—

SECONDARY outcome

Timeframe: From Baseline 2 to Week 48.

Population: Maintenance Phase Intent-to-Treat Population 2 (ITT2)

Time to virological failure (defined as HIV-1 RNA ≥ 400 copies/mL) was counted from Baseline 2 until the first of the two consecutive ≥400 copies/mL measurements.

Only patients who were qualified for entering the Maintenance Phase were included in the analyses.

Outcome measures

Measure	ENF+HAART n=19 Participants Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.	HAART n=8 Participants Participants received highly active antiretroviral treatment.	HAART (ENF Removed) Participants who had received ENF + HAART during the Induction Phase and responded to treatment by Week 24 continued to receive HAART alone during the Maintenance Phase, for a total of 48 weeks of treatment.
Time to Virological Failure During the Maintenance Phase	NA days Median time to virological failure could not be estimated due to the low number of patients with virological failure in this arm and the inter-quartile range was not calculated.	NA days Median time to virological failure could not be estimated due to the low number of patients with virological failure in this arm and the inter-quartile range was not calculated.	—

SECONDARY outcome

Timeframe: From Baseline 2 to Week 48.

Population: Maintenance Phase Intent-to-Treat Population 2 (ITT2)

Virological failure was defined by 2 consecutive HIV-1 RNA values ≥ 400 copies/mL during the Maintenance Phase.

Outcome measures

Measure	ENF+HAART n=19 Participants Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.	HAART n=8 Participants Participants received highly active antiretroviral treatment.	HAART (ENF Removed) Participants who had received ENF + HAART during the Induction Phase and responded to treatment by Week 24 continued to receive HAART alone during the Maintenance Phase, for a total of 48 weeks of treatment.
Number of Participants With Virological Failure During the Maintenance Phase	3 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Baseline 2 to Week 48.

Population: Maintenance Phase ITT2 population with a Baseline 2 CD4+ count of greater than or equal to 200 cells/mm\^3.

Maintenance of CD4+ count defined as having greater than or equal to 200 cells/mm^3 at Baseline 2 (BL2) and greater than or equal to 200 cells/mm^3 at Week 48.

Outcome measures

Measure	ENF+HAART n=9 Participants Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.	HAART n=8 Participants Participants received highly active antiretroviral treatment.	HAART (ENF Removed) n=8 Participants Participants who had received ENF + HAART during the Induction Phase and responded to treatment by Week 24 continued to receive HAART alone during the Maintenance Phase, for a total of 48 weeks of treatment.
Percentage of Participants Maintaining CD4+ Count During the Maintenance Phase Week 48 CD4+ Count ≥200 cells/mm^3	66.67 percentage of participants	75.00 percentage of participants	75.00 percentage of participants
Percentage of Participants Maintaining CD4+ Count During the Maintenance Phase Week 48 CD4+ Count Missing	33.33 percentage of participants	25.00 percentage of participants	12.50 percentage of participants

SECONDARY outcome

Timeframe: Baseline 2 to Week 48.

Population: Maintenance Phase ITT2 population with a Baseline 2 CD4+ count of ≥100 to \<200 cells/mm\^3.

Improvement of CD4+ count defined as having from 100 to less than 200 CD4+ cells/mm^3 at Baseline 2 (BL2) and greater than or equal to 200 cells/mm^3 at Week 48.

Outcome measures

Measure	ENF+HAART n=1 Participants Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.	HAART Participants received highly active antiretroviral treatment.	HAART (ENF Removed) n=1 Participants Participants who had received ENF + HAART during the Induction Phase and responded to treatment by Week 24 continued to receive HAART alone during the Maintenance Phase, for a total of 48 weeks of treatment.
Percentage of Participants With Improvement in CD4+ Count During the Maintenance Phase Week 48 CD4+ Count ≥200 cells/mm^3	100.00 percentage of participants	—	100.00 percentage of participants
Percentage of Participants With Improvement in CD4+ Count During the Maintenance Phase Week 48 CD4+ Count Missing	0 percentage of participants	—	0 percentage of participants

SECONDARY outcome

Timeframe: Start of the study treatment until the end of the Induction Phase (Week 12 to Week 32)

Population: Safety Population

A serious AE (SAE) is an event which: results in death, is life-threatening, disabling or incapacitating; is a congenital anomaly in the offspring of a patient who received study drug; requires or prolongs inpatient hospitalization; jeopardizes the patient or require medical or surgical intervention to prevent one of the outcomes above; any Grade 4 laboratory value considered by the investigator clinically significant or that requires an action; any injection site reaction that meets SAE criteria above. Non-serious AEs reported include pneumonia and non-serious AEs that led to discontinuation.

Outcome measures

Measure	ENF+HAART n=29 Participants Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.	HAART n=18 Participants Participants received highly active antiretroviral treatment.	HAART (ENF Removed) Participants who had received ENF + HAART during the Induction Phase and responded to treatment by Week 24 continued to receive HAART alone during the Maintenance Phase, for a total of 48 weeks of treatment.
Number of Participants With Adverse Events (AEs) During the Induction Phase Serious Adverse Event	3 participants	3 participants	—
Number of Participants With Adverse Events (AEs) During the Induction Phase Non-serious Adverse Event	3 participants	1 participants	—
Number of Participants With Adverse Events (AEs) During the Induction Phase Adverse Events Leading to Withdrawal	5 participants	1 participants	—

Adverse Events

Induction: ENF+HAART

Serious events: 3 serious events

Other events: 9 other events

Deaths: 0 deaths

Induction Phase: HAART

Serious events: 3 serious events

Other events: 11 other events

Deaths: 0 deaths

Maintenance Phase: ENF + HAART

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Maintenance Phase: HAART (ENF Removed)

Serious events: 3 serious events

Other events: 4 other events

Deaths: 0 deaths

Maintenance Phase: HAART

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Induction: ENF+HAART n=29 participants at risk During the Induction Phase participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment for a maximum of 32 weeks.	Induction Phase: HAART n=18 participants at risk During the Induction Phase participants received highly active antiretroviral treatment for a maximum of 32 weeks.	Maintenance Phase: ENF + HAART n=10 participants at risk During the Maintenance Phase, participants who had received ENF+HAART and who responded to treatment during the Induction Phase continued to receive enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment for up to 48 weeks of total treatment.	Maintenance Phase: HAART (ENF Removed) n=9 participants at risk During the Maintenance Phase, participants who had received ENF+HAART and who responded to treatment during the Induction Phase continued to receive HAART alone during the Maintenance Phase, for up to a total of 48 weeks treatment.	Maintenance Phase: HAART n=8 participants at risk During the Maintenance Phase, participants who had received HAART alone and who responded to treatment during the Induction Phase continued to receive highly active antiretroviral treatment for up to 48 weeks of total treatment.
Infections and infestations PAROTITIS	0.00% 0/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	5.6% 1/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
Infections and infestations POSTOPERATIVE WOUND INFECTION	0.00% 0/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	5.6% 1/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
Gastrointestinal disorders ABDOMINAL PAIN	0.00% 0/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	5.6% 1/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
Gastrointestinal disorders VOMITING	0.00% 0/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	5.6% 1/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
Blood and lymphatic system disorders ANAEMIA	3.4% 1/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
General disorders INJECTION SITE REACTION	3.4% 1/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
Hepatobiliary disorders HEPATIC FAILURE	0.00% 0/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	5.6% 1/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
Musculoskeletal and connective tissue disorders RHABDOMYOLYSIS	3.4% 1/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
Renal and urinary disorders RENAL FAILURE	3.4% 1/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
Infections and infestations INFECTION	0.00% 0/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	11.1% 1/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
Infections and infestations PNEUMONIA	0.00% 0/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	10.0% 1/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
Hepatobiliary disorders HEPATIC FUNCTION ABNORMAL	0.00% 0/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	10.0% 1/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ANAL CANCER	0.00% 0/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	11.1% 1/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
Renal and urinary disorders CALCULUS URETERIC	0.00% 0/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	11.1% 1/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
Respiratory, thoracic and mediastinal disorders RESPIRATORY DISTRESS	0.00% 0/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	10.0% 1/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.

Other adverse events

Measure	Induction: ENF+HAART n=29 participants at risk During the Induction Phase participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment for a maximum of 32 weeks.	Induction Phase: HAART n=18 participants at risk During the Induction Phase participants received highly active antiretroviral treatment for a maximum of 32 weeks.	Maintenance Phase: ENF + HAART n=10 participants at risk During the Maintenance Phase, participants who had received ENF+HAART and who responded to treatment during the Induction Phase continued to receive enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment for up to 48 weeks of total treatment.	Maintenance Phase: HAART (ENF Removed) n=9 participants at risk During the Maintenance Phase, participants who had received ENF+HAART and who responded to treatment during the Induction Phase continued to receive HAART alone during the Maintenance Phase, for up to a total of 48 weeks treatment.	Maintenance Phase: HAART n=8 participants at risk During the Maintenance Phase, participants who had received HAART alone and who responded to treatment during the Induction Phase continued to receive highly active antiretroviral treatment for up to 48 weeks of total treatment.
Infections and infestations NASOPHARYNGITIS	0.00% 0/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	5.6% 1/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	12.5% 1/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
Psychiatric disorders INSOMNIA	0.00% 0/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	5.6% 1/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
Investigations TRANSAMINASES INCREASED	0.00% 0/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	11.1% 2/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
Investigations PLATELET COUNT DECREASED	0.00% 0/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	12.5% 1/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
Nervous system disorders HEADACHE	3.4% 1/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	5.6% 1/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
Nervous system disorders DIZZINESS	0.00% 0/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	5.6% 1/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	0.00% 0/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	5.6% 1/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	12.5% 1/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
Respiratory, thoracic and mediastinal disorders PULMONARY CONGESTION	0.00% 0/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	5.6% 1/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
Skin and subcutaneous tissue disorders RASH	3.4% 1/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	5.6% 1/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
Blood and lymphatic system disorders THROMBOCYTOPENIA	0.00% 0/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	5.6% 1/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
Ear and labyrinth disorders TINNITUS	0.00% 0/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	5.6% 1/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	12.5% 1/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
General disorders CHEST PAIN	0.00% 0/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	5.6% 1/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
Hepatobiliary disorders HEPATIC FAILURE	0.00% 0/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	5.6% 1/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
Immune system disorders DRUG HYPERSENSITIVITY	0.00% 0/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	5.6% 1/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
Metabolism and nutrition disorders ANOREXIA	0.00% 0/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	5.6% 1/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL CHEST PAIN	0.00% 0/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	5.6% 1/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	12.5% 1/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
Gastrointestinal disorders CONSTIPATION	0.00% 0/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	11.1% 1/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	12.5% 1/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
Gastrointestinal disorders DYSPHAGIA	0.00% 0/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	10.0% 1/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
Gastrointestinal disorders TOOTHACHE	0.00% 0/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	5.6% 1/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
Respiratory, thoracic and mediastinal disorders COUGH	3.4% 1/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	10.0% 1/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	11.1% 1/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	12.5% 1/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
Infections and infestations ABSCESS JAW	0.00% 0/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	11.1% 1/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
Infections and infestations INFLUENZA	0.00% 0/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	12.5% 1/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
Infections and infestations ONYCHOMYCOSIS	0.00% 0/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	10.0% 1/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
Infections and infestations PNEUMONIA BACTERIAL	0.00% 0/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	11.1% 1/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
Metabolism and nutrition disorders HYPERCHOLESTEROLAEMIA	0.00% 0/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	11.1% 1/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
Metabolism and nutrition disorders HYPERTRIGLYCERIDAEMIA	0.00% 0/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	11.1% 1/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
General disorders PAIN	0.00% 0/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	12.5% 1/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
Eye disorders CONJUNCTIVITIS	0.00% 0/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	5.6% 1/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
Injury, poisoning and procedural complications SKIN INJURY	0.00% 0/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	10.0% 1/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
Gastrointestinal disorders DIARRHOEA	6.9% 2/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	27.8% 5/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
Gastrointestinal disorders ABDOMINAL DISTENSION	3.4% 1/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	11.1% 2/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
Gastrointestinal disorders VOMITING	6.9% 2/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	5.6% 1/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
Gastrointestinal disorders NAUSEA	3.4% 1/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	5.6% 1/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
Gastrointestinal disorders ODYNOPHAGIA	3.4% 1/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	5.6% 1/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	0.00% 0/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	5.6% 1/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
Gastrointestinal disorders DRY MOUTH	0.00% 0/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	5.6% 1/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
Gastrointestinal disorders FLATULENCE	0.00% 0/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	5.6% 1/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
Infections and infestations CELLULITIS	6.9% 2/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
Infections and infestations PHARYNGITIS	0.00% 0/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	5.6% 1/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	10.0% 1/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	11.1% 1/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	12.5% 1/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
Infections and infestations BRONCHITIS	0.00% 0/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	5.6% 1/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
Infections and infestations FOLLICULITIS	0.00% 0/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	5.6% 1/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	12.5% 1/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.
Infections and infestations GINGIVAL ABSCESS	0.00% 0/29 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/18 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/10 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	0.00% 0/9 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.	12.5% 1/8 • From the start of the study treatment until 28 days after the last dose of the study medication. Per protocol, AEs of pneumonia (non-serious and serious), AEs that lead to discontinuation, and AEs that are serious were reported. Unless fatal, any acquired immunodeficiency syndrome (AIDS)-defining events (ADEs), as defined by the 1993 Center for Disease Control (CDC) AIDS Surveillance Case Definitions, are excluded from the definition of SAE.

Additional Information

Medical Communications

Hoffman-LaRoche

Phone: 800-821-8590

Results disclosure agreements

• Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
• Publication restrictions are in place

Restriction type: OTHER