Trial Outcomes & Findings for Safety and Effectiveness of Raltegravir Plus Darunavir/Ritonavir in Treatment-Naive HIV-Infected Adults (NCT NCT00830804)

NCT ID: NCT00830804

Last Updated: 2018-11-08

Results Overview

Virologic failure is defined as: at week 12, confirmed plasma HIV-1 RNA \>= 1000 copies/ml or confirmed rebound from the week 4 value by \>0.5 log10 copies/ml (for subjects with week 4 value \<= 50 copies/ml, confirmed rebound to \>50 copies/ml); at week 24 or later, confirmed value \> 50 copies/ml. Viral load confirmation was scheduled 7-35 days after initial virologic failure. The proportion was estimated using Kaplan-Meier method. An adaptation of Greenwood's variance estimate was used in constructing the confidence interval.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 113 participants
• Primary outcome timeframe: From start of study treatment to week 24
• Results posted on: 2018-11-08

Participant Flow

Study participants were recruited from 22 U.S. sites from April 2009 to August 2009.

Study participants were HIV-1-infected, antiretroviral(ARV)-naive men and women, 18 years and older with plasma HIV-1 RNA >= 5000 copies/ml. One enrolled participant never started study treatment.

Participant milestones

Measure	RAL + DRV/RTV Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
Overall Study STARTED	112
Overall Study COMPLETED	97
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Measure	RAL + DRV/RTV Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
Overall Study Lost to Follow-up	4
Overall Study Death	1
Overall Study Unable to get to clinic	7
Overall Study Consent withdrawn	2
Overall Study Unwilling to adhere to study requirement	1

Baseline Characteristics

Safety and Effectiveness of Raltegravir Plus Darunavir/Ritonavir in Treatment-Naive HIV-Infected Adults

Baseline characteristics by cohort

Measure	RAL+DRV/RTV n=112 Participants Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
Age, Continuous	36 years FULL_RANGE 11 • n=5 Participants
Age, Customized 18-29	33 participants n=5 Participants
Age, Customized 30-39	38 participants n=5 Participants
Age, Customized 40-49	25 participants n=5 Participants
Age, Customized 50-59	12 participants n=5 Participants
Age, Customized 60-69	4 participants n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	98 Participants n=5 Participants
Region of Enrollment United States	112 participants n=5 Participants

PRIMARY outcome

Timeframe: From start of study treatment to week 24

Population: All participants who started study treatment were included. The intent-to-treat approach was used, ignoring whether a participant was on or off treatment at the time of HIV-1 RNA measurement and censoring follow-up if a participant was lost-to-follow-up without previously meeting the definition of virologic failure.

Virologic failure is defined as: at week 12, confirmed plasma HIV-1 RNA >= 1000 copies/ml or confirmed rebound from the week 4 value by >0.5 log10 copies/ml (for subjects with week 4 value <= 50 copies/ml, confirmed rebound to >50 copies/ml); at week 24 or later, confirmed value > 50 copies/ml. Viral load confirmation was scheduled 7-35 days after initial virologic failure. The proportion was estimated using Kaplan-Meier method. An adaptation of Greenwood's variance estimate was used in constructing the confidence interval.

Outcome measures

Measure	RAL+DRV/RTV n=112 Participants Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
Proportion of Participants With Virologic Failure After Initiating RAL Plus DRV/RTV at or Prior to Week 24	0.16 Proportion of participants Interval 0.1 to 0.24

SECONDARY outcome

Timeframe: From start of study treatment to Week 24

Population: All participants who started study treatment were included in the analysis.

The proportion of participants with virologic failure (see primary outcome measure for definition) and/or premature treatment discontinuation/modification and/or death was estimated using Kaplan-Meier method. An adaptation of Greenwood's variance estimate was used in constructing the confidence interval.

Outcome measures

Measure	RAL+DRV/RTV n=112 Participants Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
Proportion of Participants With Virologic Failure or Off Study Treatment Regimen or Death at or Prior to Week 24	0.21 Proportion of participants Interval 0.14 to 0.29

SECONDARY outcome

Timeframe: Baseline and week 1

Population: Analyis was based on an intent-to-treat approach, ignoring whether a participant was on or off study treatment at the time the sample for HIV-1 RNA was obtained.

Results report the week 1 change from baseline (week 1 - baseline) in HIV-1 RNA. Baseline HIV-1 RNA was computed as the mean of the log10 HIV-1 RNA values at pre-entry and study entry.

Outcome measures

Measure	RAL+DRV/RTV n=112 Participants Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
Change in Plasma HIV-1 RNA From Baseline to Week 1	-1.67 log10 copies/ml Interval -1.93 to -1.42

SECONDARY outcome

Timeframe: From start of study treatment to week 24

Population: All participants who started study treatment were included. An intent-to-treat approach was used ignoring participants who were off-study or with missing HIV-1 RNA at week 24.

Results report the percentage of participants with plasma HIV-1 RNA < 50 copies/ml or <200 copies/ml at week 24.

Outcome measures

Measure	RAL+DRV/RTV n=107 Participants Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
Proportion of Participants With Plasma HIV-1 RNA < 50 Copies/ml or <200 Copies/ml at Week 24 With HIV-1 RNA < 200 copies/ml	0.93 proportion of participants Interval 0.87 to 0.97
Proportion of Participants With Plasma HIV-1 RNA < 50 Copies/ml or <200 Copies/ml at Week 24 With HIV-1 RNA < 50 copies/ml	0.79 proportion of participants Interval 0.7 to 0.86

SECONDARY outcome

Timeframe: From start of study treatment to week 48

Population: All participants who started study treatment were included. An intent-to-treat approach was used ignoring participants who were off study treatment or with missing HIV-1 RNA at week 48.

Results report the percentage of participants with plasma HIV-1 RNA <50 copies/ml or <200 copies/ml at week 48.

Outcome measures

Measure	RAL+DRV/RTV n=100 Participants Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
Proportion of Participants With Plasma HIV-1 RNA <50 Copies/ml or <200 Copies/ml at Week 48 With HIV-1 RNA < 50 copies/ml	0.71 proportion of participants Interval 0.61 to 0.79
Proportion of Participants With Plasma HIV-1 RNA <50 Copies/ml or <200 Copies/ml at Week 48 With HIV-1 RNA < 200 copies/ml	0.86 proportion of participants Interval 0.78 to 0.92

SECONDARY outcome

Timeframe: From start of study treatment to week 52

Population: All participants who started study treatment were included in the analysis.

Signs, symptoms and laboratory values were graded according to the Division of AIDS Adverse Event Grading System. Results report the percentage of participants who had grade 3 or higher events, or events of any grade which led to a permanent change or discontinuation of study treatment, which occurred any time from start of treatment to end of treatment.

Outcome measures

Measure	RAL+DRV/RTV n=112 Participants Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
Proportion of Participants Who Experienced Signs/Symptoms or Laboratory Toxicities Grade 3 or Higher, or of Any Grade Which Led to a Permanent Change or Discontinuation of Study Treatment	0.20 proportion of participants Interval 0.13 to 0.28

SECONDARY outcome

Timeframe: At screening

Population: All participants who started study treatment were included in the analysis.

Results report the number of participants who had resistance to non-nucleoside reverse transciptase inhibitors (NNRTI), nucleoside reverse transciptase inhibitors (NRTI) and protease inbitors (PI) based on genotypic resistance testing done prior to participant's entry into the study. Participants are classified into one (and only one category) based on the maximum number of drug class resistance seen for the participant.

Outcome measures

Measure	RAL+DRV/RTV n=112 Participants Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
Number of Participants With Pretreatment Drug Resistance With NNRTI mutations only	9 participants
Number of Participants With Pretreatment Drug Resistance With NRTI mutations only	8 participants
Number of Participants With Pretreatment Drug Resistance With Both NNRTI and NRTI mutations	1 participants
Number of Participants With Pretreatment Drug Resistance With PI mutations only	2 participants
Number of Participants With Pretreatment Drug Resistance With PI, NNRTI and NRTI mutations	1 participants
Number of Participants With Pretreatment Drug Resistance No Resistance Detected	91 participants

SECONDARY outcome

Timeframe: From 12 weeks after starting study treatment to week 52

Population: Only those participants who had virologic failure (see primary outcome measure for definition) and who had successful integrase genotyping at failure were included in the analysis.

Results report the number of participants who had integrase resistance mutation(s) detected at the time of virologic failure.

Outcome measures

Measure	RAL+DRV/RTV n=25 Participants Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
Number of Participants With Integrase Drug Resistance at Virologic Failure	5 participants

SECONDARY outcome

Timeframe: From 12 weeks after starting study treatment to week 52

Population: Only those participants who had virologic failure (see primary outcome measure for definition) and who had successful protease genotyping at failure were included in the analysis.

Results report the number of participants who had protease resistance mutation(s) detected at the time of virologic failure.

Outcome measures

Measure	RAL+DRV/RTV n=23 Participants Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
Number of Participants With Protease Drug Resistance at Virologic Failure	0 participants

SECONDARY outcome

Timeframe: From one week after starting study treatment to week 52

Population: All participants who started study treatment were included in the analysis.

At each study visit, adherence was measured in terms of the number of missed doses each participant had over a 4-day recall for each drug. Adherence for all study visit weeks were combined for an overall measure of adherence. Participants who had zero missed doses on all weeks in all drugs while on study were classified as having an overall "perfect" adherence.

Outcome measures

Measure	RAL+DRV/RTV n=112 Participants Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
Number of Participants With Perfect Overall Adherence by Self Report	95 participants

SECONDARY outcome

Timeframe: From start of study treatment through week 24

Population: Only those participants who started study treatment and who had fasting lipid measurements at week 24 and week 0 were included in the analysis.

Results report the week 24 change from week 0 (week 24 - week 0) fasting total cholesterol, high-density lipoprotein and triglyceride.

Outcome measures

Measure	RAL+DRV/RTV n=94 Participants Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
Changes in Fasting Total Cholesterol, High-density Lipoprotein and Triglyceride at Week 24 Fasting Total Cholesterol	31.5 mg/dL Interval 12.0 to 46.0
Changes in Fasting Total Cholesterol, High-density Lipoprotein and Triglyceride at Week 24 Fasting High-density Lipoprotein	6.5 mg/dL Interval 1.0 to 15.0
Changes in Fasting Total Cholesterol, High-density Lipoprotein and Triglyceride at Week 24 Fasting Triglyceride	24.5 mg/dL Interval -6.0 to 64.0

SECONDARY outcome

Timeframe: From start of study treatment through week 24

Population: Only those participants who started study treatment and who had fasting lipid measurements at week 24 and week 0 were included in the analysis.

Results report the week 24 change from week 0 (week 24 - week 0) fasting low-density lipoprotein (LDL). For participants whose calculated fasting LDL and direct fasting LDL were both reported, only the calculated fasting LDL was used. Direct fasting LDL was reported when the participant had high fasting triglyceride.

Outcome measures

Measure	RAL+DRV/RTV n=82 Participants Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
Change in Fasting Low-density Lipoprotein at Week 24	16.0 mg/dL Interval 5.0 to 36.0

SECONDARY outcome

Timeframe: From start of study treatment through week 48

Population: Only those participants who started study treatment and who had fasting lipid measurements at week 48 and week 0 were included in the analysis.

Results report the week 48 change from week 0 (week 48 - week 0) fasting total cholesterol, high-density lipoprotein and triglyceride.

Outcome measures

Measure	RAL+DRV/RTV n=85 Participants Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
Changes in Fasting Total Cholesterol, High-density Lipoprotein and Triglyceride at Week 48 Fasting Total Cholesterol	30 mg/dL Interval 10.0 to 59.0
Changes in Fasting Total Cholesterol, High-density Lipoprotein and Triglyceride at Week 48 Fasting High-density Lipoprotein	9 mg/dL Interval 2.0 to 17.0
Changes in Fasting Total Cholesterol, High-density Lipoprotein and Triglyceride at Week 48 Fasting Triglyceride	23 mg/dL Interval -31.0 to 81.0

SECONDARY outcome

Timeframe: From start of study treatment through week 48

Population: Only those participants who started study treatment and who had fasting lipid measurements at week 48 and week 0 were included in the analysis.

Results report the week 48 change from week 0 (week 48 - week 0) fasting low-density lipoprotein (LDL). For participants whose calculated fasting LDL and direct fasting LDL were both reported, only the calculated fasting LDL was used. Direct fasting LDL was reported when the participant had high fasting triglyceride.

Outcome measures

Measure	RAL+DRV/RTV n=70 Participants Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
Change in Fasting Low-density Lipoprotein at Week 48	17 mg/dL Interval 2.0 to 33.0

SECONDARY outcome

Timeframe: From start of study treatment through week 48

Population: Only those participants who started study treatment and who have values at baseline and at week 48 were included in the analysis.

Results report the week 48 change from baseline (week 48 - baseline) in CD4 count. Baseline CD4 count was computed as the mean of CD4 count values at pre-entry and study entry.

Outcome measures

Measure	RAL+DRV/RTV n=100 Participants Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
Change in CD4 Count at Week 48	200 cells/mm3 Interval 114.0 to 318.0

SECONDARY outcome

Timeframe: From start of study treatment to week 52

Population: Participants who started study treatment and who have at least one RAL plasma trough concentration obtained within 9-15 hours after the last RAL dose were included in the analysis.

Plasma trough concentrations (ng/ml) of Raltegravir (RAL) below the detection limit (10 ng/ml) were replaced by half the corresponding lower limit of quantitation. Geometric mean of trough concentrations obtained within the prescribed trough time (within 9-15 hours after the last RAL dose) was computed for each participant. For participants who experienced virologic failure (see primary outcome measure definition), only those concentrations on or before virologic failure confirmation were used in the geometric mean computation.

Outcome measures

Measure	RAL+DRV/RTV n=103 Participants Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
Plasma Trough Concentration of Raltegravir	117 ng/ml Interval 52.0 to 250.0

SECONDARY outcome

Timeframe: From start of study treatment to week 52

Population: Participants who started study treatment and who have at least one DRV plasma trough concentration obtained within 20-28 hours after the last DRV dose were included in the analysis.

Plasma trough concentrations (ng/ml) of Darunavir (DRV) below the detection limit (50 ng/ml) were replaced by half the corresponding lower limit of quantitation. Geometric mean of trough concentrations obtained within the prescribed trough time (within 20-28 hours after the last DRV dose) was computed for each participant. For participants who experienced virologic failure (see primary outcome measure definition), only those concentrations on or before virologic failure confirmation were used in the geometric mean computation.

Outcome measures

Measure	RAL+DRV/RTV n=83 Participants Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
Plasma Trough Concentration of Darunavir	1218 ng/ml Interval 789.0 to 1809.0

Adverse Events

RAL+DRV/RTV

Serious events: 13 serious events

Other events: 78 other events

Deaths: 0 deaths

Serious adverse events

Measure	RAL+DRV/RTV n=112 participants at risk Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
Gastrointestinal disorders Diarrhoea	0.89% 1/112 • From start of study treatment to week 52 Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.
Gastrointestinal disorders Jejunal perforation	0.89% 1/112 • From start of study treatment to week 52 Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.
General disorders Injection site reaction	0.89% 1/112 • From start of study treatment to week 52 Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.
Infections and infestations Bronchitis	0.89% 1/112 • From start of study treatment to week 52 Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.
Infections and infestations Perirectal abscess	0.89% 1/112 • From start of study treatment to week 52 Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.
Infections and infestations Pneumonia	1.8% 2/112 • From start of study treatment to week 52 Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.
Injury, poisoning and procedural complications Alcohol poisoning	0.89% 1/112 • From start of study treatment to week 52 Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.
Metabolism and nutrition disorders Diabetes mellitus	0.89% 1/112 • From start of study treatment to week 52 Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.
Nervous system disorders Convulsion	0.89% 1/112 • From start of study treatment to week 52 Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.
Nervous system disorders Syncope	0.89% 1/112 • From start of study treatment to week 52 Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.
Psychiatric disorders Substance abuse	0.89% 1/112 • From start of study treatment to week 52 Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.
Psychiatric disorders Suicide attempt	0.89% 1/112 • From start of study treatment to week 52 Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.
Renal and urinary disorders Renal failure acute	0.89% 1/112 • From start of study treatment to week 52 Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.
Skin and subcutaneous tissue disorders Henoch-Schonlein purpura	0.89% 1/112 • From start of study treatment to week 52 Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.

Other adverse events

Measure	RAL+DRV/RTV n=112 participants at risk Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
Gastrointestinal disorders Nausea	5.4% 6/112 • From start of study treatment to week 52 Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.
Investigations Alanine aminotransferase increased	9.8% 11/112 • From start of study treatment to week 52 Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.
Investigations Aspartate aminotransferase increased	13.4% 15/112 • From start of study treatment to week 52 Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.
Investigations Blood cholesterol	40.2% 45/112 • From start of study treatment to week 52 Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.
Investigations Blood glucose abnormal	7.1% 8/112 • From start of study treatment to week 52 Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.
Investigations Blood sodium decreased	5.4% 6/112 • From start of study treatment to week 52 Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.
Investigations Blood uric acid increased	8.0% 9/112 • From start of study treatment to week 52 Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.
Investigations Low density lipoprotein abnormal	30.4% 34/112 • From start of study treatment to week 52 Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.
Investigations Neutrophil count decreased	12.5% 14/112 • From start of study treatment to week 52 Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.
Investigations White blood cell count decreased	7.1% 8/112 • From start of study treatment to week 52 Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.
Psychiatric disorders Depression	6.2% 7/112 • From start of study treatment to week 52 Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.

Additional Information

ACTG ClinicalTrials.gov Coordinator

ACTG Network Coordinating Center, Social and Scientific Systems, Inc.

Phone: (301) 628-3313

Email: ACTGCT.Gov@s-3.com

Results disclosure agreements

• Principal investigator is a sponsor employee In accordance with the Clinical Trial Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.
• Publication restrictions are in place

Restriction type: OTHER