Trial Outcomes & Findings for Safety and Effectiveness of Lopinavir/Ritonavir in Individuals Who Have Failed Prior HIV Therapy (NCT NCT00357552)

Last Updated: 2018-03-20

Results Overview

Virologic success at week 24 on LPV/r monotherapy was defined as remaining on LPV/r monotherapy at week 24 without prior virologic failure. Virologic failure was met with either of these two conditions: (i) failure to suppress HIV-1 RNA to \< 400 copies/mL by week 24 or (ii) confirmed HIV-1 RNA \>= 400 copies/mL after confirmed HIV-1 RNA \< 400 copies/mL.

Recruitment status

COMPLETED

Study phase

Target enrollment

123 participants

Primary outcome timeframe

From study entry to week 24

Results posted on

2018-03-20

Participant Flow

Participant milestones

Participant milestones
Measure	LPV/r Monotherapy Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
Screening STARTED	207
Screening COMPLETED	123
Screening NOT COMPLETED	84
Weeks 0 to 24 STARTED	123
Weeks 0 to 24 COMPLETED	122
Weeks 0 to 24 NOT COMPLETED	1
Weeks 24 to 104 STARTED	122
Weeks 24 to 104 COMPLETED	117
Weeks 24 to 104 NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	LPV/r Monotherapy Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
Screening Did not meet eligibility criteria	84
Weeks 0 to 24 Death	1
Weeks 24 to 104 Death	3
Weeks 24 to 104 Not able to get to clinic	2

Baseline Characteristics

Safety and Effectiveness of Lopinavir/Ritonavir in Individuals Who Have Failed Prior HIV Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LPV/r Monotherapy n=123 Participants Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	123 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	39.4 years STANDARD_DEVIATION 8.2 • n=5 Participants
Sex: Female, Male Female	70 Participants n=5 Participants
Sex: Female, Male Male	53 Participants n=5 Participants
Region of Enrollment South Africa	22 participants n=5 Participants
Region of Enrollment Thailand	24 participants n=5 Participants
Region of Enrollment India	12 participants n=5 Participants
Region of Enrollment Malawi	40 participants n=5 Participants
Region of Enrollment Tanzania	25 participants n=5 Participants

PRIMARY outcome

Timeframe: From study entry to week 24

Population: All enrolled individuals.

Outcome measures

Outcome measures
Measure	LPV/r Monotherapy n=123 Participants Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
Percentage of Enrolled Participants With Virologic Success at Week 24 on LPV/r Monotherapy	87 percentage of enrolled subjects Interval 81.0 to 92.0

PRIMARY outcome

Timeframe: From study entry to week 24

Population: All enrolled individuals.

Probability of Grade 3 or 4 sign or symptom, or laboratory toxicity over 24 weeks on study using Kaplan-Meier estimates of the cumulative probability of Grade 3 or 4 sign or symptom, or laboratory toxicity at week 24. Grading of adverse events (signs and symptoms and laboratory toxicities) was according to Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004.

Outcome measures

Outcome measures
Measure	LPV/r Monotherapy n=123 Participants Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
Probability of Grade 3 or 4 Sign or Symptom, or Laboratory Toxicity Over 24 Weeks on Study.	0.23 cumulative probability of grade 3 or 4 Interval 0.16 to 0.31

SECONDARY outcome

Timeframe: Screening

Population: All screened individuals.

Number of screened subjects with at least one NNRTI, or NRTI-associated resistance mutation. Resistance interpretations used the November 30, 2011 Stanford algorithm.

Outcome measures

Outcome measures
Measure	LPV/r Monotherapy n=207 Participants Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
Number of Screened Subjects With at Least One NNRTI, or NRTI-associated Resistance Mutation at A5230 Screening. At least one NNRTI-associated mutation	201 number of screened subjects
Number of Screened Subjects With at Least One NNRTI, or NRTI-associated Resistance Mutation at A5230 Screening. At least one NRTI-associated mutation	197 number of screened subjects

SECONDARY outcome

Timeframe: Study entry to Week 104

Population: All participants enrolled.

25th percentile in weeks from study entry to treatment failure, defined as the first occurrence of death, disease progression, or virologic failure. Virologic failure was defined as HIV-1 \>= 400 copies/mL after week 24 or 2 consecutive HIV-1 RNA \>= 400 copies/mL after week 16 following suppression on LPV/r monotherapy.

Outcome measures

Outcome measures
Measure	LPV/r Monotherapy n=123 Participants Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
Time to Treatment Failure, Defined as the First Occurrence of Death, Disease Progression, or Virologic Failure.	48.0 weeks Interval 40.0 to 80.0

SECONDARY outcome

Timeframe: Study entry to week 104

Population: All participants enrolled.

Cardiac disorders, Infections and infestations, Metabolism and nutrition disorders, Neoplasms benign, malignant and unspecified (including cysts and polyps), Pregnancy, puerperium and perinatal conditions, Vascular disorders, were specified a priori as study-targeted events by the study chair.

Outcome measures

Outcome measures
Measure	LPV/r Monotherapy n=123 Participants Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
Number of Participants With Study-targeted Diagnoses and Clinical Events	39 participants

SECONDARY outcome

Timeframe: At time of virologic failure

Population: 16 subjects met the criteria for endpoint failure; 15 subjects were virologic failures and 1 subject intensified prior to virologic failure. Of the 15 subjects with virologic failure, 11 had sequence data, and sequencing failed for 4.

Number of subjects with at least one new PI-associated resistance mutation at time of virologic failure. Resistance interpretations used the May 6, 2009 Stanford algorithm.

Outcome measures

Outcome measures
Measure	LPV/r Monotherapy n=11 Participants Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
Number of Subjects With at Least One New PI-associated Resistance Mutation at Time of Virologic Failure.	2 participants

SECONDARY outcome

Timeframe: Study entry and weeks 2, 4, 8, 12, 16, 20, and 24

Population: All participants enrolled.

The percentage of subjects reporting never missing medications in the last month.

Outcome measures

Outcome measures
Measure	LPV/r Monotherapy n=123 Participants Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
Percentage of Subjects Reporting Not Skipping Medications in the Last Month. week 20 (N=120)	90.9 percentage of subjects with data
Percentage of Subjects Reporting Not Skipping Medications in the Last Month. week 2 (N=120)	90 percentage of subjects with data
Percentage of Subjects Reporting Not Skipping Medications in the Last Month. week 4 (N=121)	86.8 percentage of subjects with data
Percentage of Subjects Reporting Not Skipping Medications in the Last Month. week 8 (N=123)	87.8 percentage of subjects with data
Percentage of Subjects Reporting Not Skipping Medications in the Last Month. week 12 (N=123)	86.2 percentage of subjects with data
Percentage of Subjects Reporting Not Skipping Medications in the Last Month. week 16 (N=122)	86.1 percentage of subjects with data
Percentage of Subjects Reporting Not Skipping Medications in the Last Month. week 24 (N=122)	89.4 percentage of subjects with data

SECONDARY outcome

Timeframe: From LPV/r intensification to week 104

Population: All participants enrolled.

25th percentile in weeks from study entry to first new grade 3 or 4 sign or symptom or laboratory toxicity following LPV/r intensification. Grading of adverse events (signs and symptoms and laboratory toxicities) was according to Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004.

Outcome measures

Outcome measures
Measure	LPV/r Monotherapy n=123 Participants Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
Time to First New Grade 3 or 4 Sign or Symptom or Laboratory Toxicity Following LPV/r Intensification	26.0 weeks Interval 13.1 to 53.3

SECONDARY outcome

Timeframe: At study entry and weeks 24 and 48

Population: Participants with DBS samples available at study entry, week 24 or 48, with corresponding plasma HIV-1 RNA levels.

Proportion of DBS samples with HIV-1 RNA level \<= 400 copies/mL, proportion of plasma samples with HIV-1 RNA level \<= 400 copies/mL and proportion of paired DBS and plasma samples that are concordant (both \<= 400 copies/mL or both \> 400 copies/mL). Results are pooled over 4 different storage temperature conditions (-80C, -20C, 4C and room temperature).

Outcome measures

Outcome measures
Measure	LPV/r Monotherapy n=140 paired DBS and plasma samples Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
Level of HIV-1 RNA as Ascertained From Paired DBS and Plasma week 24 DBS & plasma concordance	0.80 proportion of samples
Level of HIV-1 RNA as Ascertained From Paired DBS and Plasma week 48 DBS <= 400 cp/mL	0.94 proportion of samples
Level of HIV-1 RNA as Ascertained From Paired DBS and Plasma week 48 plasma <= 400 cp/mL	0.91 proportion of samples
Level of HIV-1 RNA as Ascertained From Paired DBS and Plasma study entry DBS <= 400 cp/mL	0.17 proportion of samples
Level of HIV-1 RNA as Ascertained From Paired DBS and Plasma study entry plasma <= 400 cp/mL	0.00 proportion of samples
Level of HIV-1 RNA as Ascertained From Paired DBS and Plasma study entry DBS & plasma concordance	0.83 proportion of samples
Level of HIV-1 RNA as Ascertained From Paired DBS and Plasma week 24 DBS <= 400 cp/mL	0.82 proportion of samples
Level of HIV-1 RNA as Ascertained From Paired DBS and Plasma week 24 plasma <= 400 cp/mL	0.80 proportion of samples
Level of HIV-1 RNA as Ascertained From Paired DBS and Plasma week 48 DBS & plasma concordance	0.97 proportion of samples

SECONDARY outcome

Timeframe: At study entry and virologic failure

Population: HIV-1 viral sequence testing in DBS was not performed

HIV-1 viral sequencing as ascertained from paired DBS and plasma

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Weeks 0, 12, 16, 20, 24, 32, 40, 48, 56, 68, 80, 92, 104

Population: All participants enrolled.

Outcome measures

Outcome measures
Measure	LPV/r Monotherapy n=123 Participants Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
Proportion of Participants With Plasma HIV-1 RNA Levels < 400 Copies/mL From Baseline to Week 104 week 0 (N=123)	0.02 proportion of participants
Proportion of Participants With Plasma HIV-1 RNA Levels < 400 Copies/mL From Baseline to Week 104 week 12 (N=122)	0.75 proportion of participants
Proportion of Participants With Plasma HIV-1 RNA Levels < 400 Copies/mL From Baseline to Week 104 week 16 (N=121)	0.87 proportion of participants
Proportion of Participants With Plasma HIV-1 RNA Levels < 400 Copies/mL From Baseline to Week 104 week 20 (N=115)	0.84 proportion of participants
Proportion of Participants With Plasma HIV-1 RNA Levels < 400 Copies/mL From Baseline to Week 104 week 24 (N=122)	0.84 proportion of participants
Proportion of Participants With Plasma HIV-1 RNA Levels < 400 Copies/mL From Baseline to Week 104 week 32 (N=121)	0.83 proportion of participants
Proportion of Participants With Plasma HIV-1 RNA Levels < 400 Copies/mL From Baseline to Week 104 week 40 (N=118)	0.84 proportion of participants
Proportion of Participants With Plasma HIV-1 RNA Levels < 400 Copies/mL From Baseline to Week 104 week 48 (N=118)	0.87 proportion of participants
Proportion of Participants With Plasma HIV-1 RNA Levels < 400 Copies/mL From Baseline to Week 104 week 56 (N=120)	0.86 proportion of participants
Proportion of Participants With Plasma HIV-1 RNA Levels < 400 Copies/mL From Baseline to Week 104 week 68 (N=116)	0.91 proportion of participants
Proportion of Participants With Plasma HIV-1 RNA Levels < 400 Copies/mL From Baseline to Week 104 week 80 (N=117)	0.85 proportion of participants
Proportion of Participants With Plasma HIV-1 RNA Levels < 400 Copies/mL From Baseline to Week 104 week 92 (N=116)	0.87 proportion of participants
Proportion of Participants With Plasma HIV-1 RNA Levels < 400 Copies/mL From Baseline to Week 104 week 104 (N=117)	0.89 proportion of participants

SECONDARY outcome

Timeframe: Study entry and week 104

Population: All participants enrolled.

Outcome measures

Outcome measures
Measure	LPV/r Monotherapy n=123 Participants Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
Change in CD4+ Cell Counts From Study Entry to Week 104	213 cells/mm^3 Interval 111.0 to 326.0

Adverse Events

LPV/r

Serious events: 20 serious events

Other events: 122 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	LPV/r n=123 participants at risk Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
Metabolism and nutrition disorders Dyslipidaemia	0.81% 1/123 • From study entry up to 104 weeks. The protocol required reporting of all signs, symptoms and laboratory abnormalities \>= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.
Metabolism and nutrition disorders Hyperglycaemia	3.3% 4/123 • From study entry up to 104 weeks. The protocol required reporting of all signs, symptoms and laboratory abnormalities \>= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.
Metabolism and nutrition disorders Hyperlipidaemia	1.6% 2/123 • From study entry up to 104 weeks. The protocol required reporting of all signs, symptoms and laboratory abnormalities \>= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.81% 1/123 • From study entry up to 104 weeks. The protocol required reporting of all signs, symptoms and laboratory abnormalities \>= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.81% 1/123 • From study entry up to 104 weeks. The protocol required reporting of all signs, symptoms and laboratory abnormalities \>= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.
Nervous system disorders Headache	0.81% 1/123 • From study entry up to 104 weeks. The protocol required reporting of all signs, symptoms and laboratory abnormalities \>= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.81% 1/123 • From study entry up to 104 weeks. The protocol required reporting of all signs, symptoms and laboratory abnormalities \>= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.
Surgical and medical procedures Diabetes mellitus management	0.81% 1/123 • From study entry up to 104 weeks. The protocol required reporting of all signs, symptoms and laboratory abnormalities \>= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.
Vascular disorders Deep vein thrombosis	0.81% 1/123 • From study entry up to 104 weeks. The protocol required reporting of all signs, symptoms and laboratory abnormalities \>= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.
Cardiac disorders Acute myocardial infarction	0.81% 1/123 • From study entry up to 104 weeks. The protocol required reporting of all signs, symptoms and laboratory abnormalities \>= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.
Gastrointestinal disorders Diarrhoea	0.81% 1/123 • From study entry up to 104 weeks. The protocol required reporting of all signs, symptoms and laboratory abnormalities \>= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.
General disorders Death	0.81% 1/123 • From study entry up to 104 weeks. The protocol required reporting of all signs, symptoms and laboratory abnormalities \>= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.
Infections and infestations Gastroenteritis	1.6% 2/123 • From study entry up to 104 weeks. The protocol required reporting of all signs, symptoms and laboratory abnormalities \>= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.
Infections and infestations Pneumonia bacterial	0.81% 1/123 • From study entry up to 104 weeks. The protocol required reporting of all signs, symptoms and laboratory abnormalities \>= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.
Investigations Blood cholesterol increased	0.81% 1/123 • From study entry up to 104 weeks. The protocol required reporting of all signs, symptoms and laboratory abnormalities \>= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.
Investigations Blood phosphorus decreased	0.81% 1/123 • From study entry up to 104 weeks. The protocol required reporting of all signs, symptoms and laboratory abnormalities \>= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.
Investigations Blood triglycerides increased	1.6% 2/123 • From study entry up to 104 weeks. The protocol required reporting of all signs, symptoms and laboratory abnormalities \>= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.
Investigations Low density lipoprotein increased	0.81% 1/123 • From study entry up to 104 weeks. The protocol required reporting of all signs, symptoms and laboratory abnormalities \>= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.

Other adverse events

Other adverse events
Measure	LPV/r n=123 participants at risk Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
Gastrointestinal disorders Abdominal pain	6.5% 8/123 • From study entry up to 104 weeks. The protocol required reporting of all signs, symptoms and laboratory abnormalities \>= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.
Gastrointestinal disorders Diarrhoea	10.6% 13/123 • From study entry up to 104 weeks. The protocol required reporting of all signs, symptoms and laboratory abnormalities \>= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.
Gastrointestinal disorders Nausea	5.7% 7/123 • From study entry up to 104 weeks. The protocol required reporting of all signs, symptoms and laboratory abnormalities \>= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.
Gastrointestinal disorders Vomiting	9.8% 12/123 • From study entry up to 104 weeks. The protocol required reporting of all signs, symptoms and laboratory abnormalities \>= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.
General disorders Chest pain	10.6% 13/123 • From study entry up to 104 weeks. The protocol required reporting of all signs, symptoms and laboratory abnormalities \>= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.
General disorders Pain	7.3% 9/123 • From study entry up to 104 weeks. The protocol required reporting of all signs, symptoms and laboratory abnormalities \>= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.
General disorders Pyrexia	22.0% 27/123 • From study entry up to 104 weeks. The protocol required reporting of all signs, symptoms and laboratory abnormalities \>= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.
Infections and infestations Malaria	8.9% 11/123 • From study entry up to 104 weeks. The protocol required reporting of all signs, symptoms and laboratory abnormalities \>= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.
Infections and infestations Nasopharyngitis	6.5% 8/123 • From study entry up to 104 weeks. The protocol required reporting of all signs, symptoms and laboratory abnormalities \>= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.
Infections and infestations Pneumonia bacterial	7.3% 9/123 • From study entry up to 104 weeks. The protocol required reporting of all signs, symptoms and laboratory abnormalities \>= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.
Infections and infestations Upper respiratory tract infection	17.9% 22/123 • From study entry up to 104 weeks. The protocol required reporting of all signs, symptoms and laboratory abnormalities \>= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.
Infections and infestations Urinary tract infection	5.7% 7/123 • From study entry up to 104 weeks. The protocol required reporting of all signs, symptoms and laboratory abnormalities \>= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.
Investigations Alanine aminotransferase increased	17.9% 22/123 • From study entry up to 104 weeks. The protocol required reporting of all signs, symptoms and laboratory abnormalities \>= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.
Investigations Aspartate aminotransferase increased	14.6% 18/123 • From study entry up to 104 weeks. The protocol required reporting of all signs, symptoms and laboratory abnormalities \>= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.
Investigations Blood albumin decreased	17.9% 22/123 • From study entry up to 104 weeks. The protocol required reporting of all signs, symptoms and laboratory abnormalities \>= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.
Investigations Blood alkaline phosphatase increased	8.1% 10/123 • From study entry up to 104 weeks. The protocol required reporting of all signs, symptoms and laboratory abnormalities \>= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.
Investigations Blood bicarbonate decreased	19.5% 24/123 • From study entry up to 104 weeks. The protocol required reporting of all signs, symptoms and laboratory abnormalities \>= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.
Investigations Blood bilirubin increased	5.7% 7/123 • From study entry up to 104 weeks. The protocol required reporting of all signs, symptoms and laboratory abnormalities \>= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.
Investigations Blood cholesterol increased	61.8% 76/123 • From study entry up to 104 weeks. The protocol required reporting of all signs, symptoms and laboratory abnormalities \>= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.
Investigations Blood glucose decreased	7.3% 9/123 • From study entry up to 104 weeks. The protocol required reporting of all signs, symptoms and laboratory abnormalities \>= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.
Investigations Blood glucose increased	25.2% 31/123 • From study entry up to 104 weeks. The protocol required reporting of all signs, symptoms and laboratory abnormalities \>= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.
Investigations Blood phosphorus decreased	31.7% 39/123 • From study entry up to 104 weeks. The protocol required reporting of all signs, symptoms and laboratory abnormalities \>= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.
Investigations Blood potassium decreased	14.6% 18/123 • From study entry up to 104 weeks. The protocol required reporting of all signs, symptoms and laboratory abnormalities \>= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.
Investigations Blood sodium decreased	50.4% 62/123 • From study entry up to 104 weeks. The protocol required reporting of all signs, symptoms and laboratory abnormalities \>= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.
Investigations Blood triglycerides increased	17.9% 22/123 • From study entry up to 104 weeks. The protocol required reporting of all signs, symptoms and laboratory abnormalities \>= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.
Investigations Haemoglobin decreased	12.2% 15/123 • From study entry up to 104 weeks. The protocol required reporting of all signs, symptoms and laboratory abnormalities \>= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.
Investigations Low density lipoprotein increased	43.9% 54/123 • From study entry up to 104 weeks. The protocol required reporting of all signs, symptoms and laboratory abnormalities \>= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.
Investigations Neutrophil count decreased	30.9% 38/123 • From study entry up to 104 weeks. The protocol required reporting of all signs, symptoms and laboratory abnormalities \>= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.
Investigations Platelet count decreased	8.1% 10/123 • From study entry up to 104 weeks. The protocol required reporting of all signs, symptoms and laboratory abnormalities \>= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.
Investigations White blood cell count decreased	15.4% 19/123 • From study entry up to 104 weeks. The protocol required reporting of all signs, symptoms and laboratory abnormalities \>= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.
Nervous system disorders Headache	17.1% 21/123 • From study entry up to 104 weeks. The protocol required reporting of all signs, symptoms and laboratory abnormalities \>= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.
Respiratory, thoracic and mediastinal disorders Cough	27.6% 34/123 • From study entry up to 104 weeks. The protocol required reporting of all signs, symptoms and laboratory abnormalities \>= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	10.6% 13/123 • From study entry up to 104 weeks. The protocol required reporting of all signs, symptoms and laboratory abnormalities \>= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	5.7% 7/123 • From study entry up to 104 weeks. The protocol required reporting of all signs, symptoms and laboratory abnormalities \>= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee In accordance with the Clinical Trials 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