Trial Outcomes & Findings for Antiviral Responses to NNRTI-Based vs. PI-Based ARV Therapy in HIV Infected Infants Who Have or Have Not Received Single Dose NVP for Prevention of Mother-to-Child Transmission of HIV (NCT NCT00307151)

Last Updated: 2017-04-13

Results Overview

Treatment failure is defined as a confirmed plasma HIV-1 RNA level that is \<1 log10 copies/mL below the study entry value at 12 to 24 weeks after treatment is initiated OR a confirmed plasma HIV-1 RNA level \>400 copies/mL at 24 weeks OR permanent discontinuation of the randomized NNRTI or PI component of study treatment at or prior to 24 weeks of treatment for any reason including death. Results report percent of participants reaching a treatment failure endpoint by week 24 calculated using the Kaplan-Meier method.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

452 participants

Primary outcome timeframe

Earlier of 24 weeks or date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009; Coh II: October 27, 2010)

Results posted on

2017-04-13

Participant Flow

Study participants were recruited at 10 study sites, 4 in South Africa and 1 each in Uganda, Zimbabwe, Zambia, Malawi, Tanzania and India between November 9, 2006 and March 19, 2010.

Infants and children 6 - 36 months of age (lower age limit changed to 2 months in Protocol Version 4.0) were stratified by age (2-\<6 months, 6-\<12 months and \>=12 months) and randomly assigned to receive either AZT/3TC/NVP or AZT/3TC/LPV/r. One subject was randomized but never started study treatment.

Participant milestones

Participant milestones
Measure	Coh I: NVP Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.	Coh I: LPV/r Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.	Coh II: NVP Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen	Coh II: LPV/r Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
Overall Study STARTED	82	82	147	140
Overall Study COMPLETED	71	75	127	129
Overall Study NOT COMPLETED	11	7	20	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Coh I: NVP Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.	Coh I: LPV/r Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.	Coh II: NVP Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen	Coh II: LPV/r Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
Overall Study Death	4	3	10	3
Overall Study Severe debilitation, unable to continue	1	0	0	0
Overall Study Subject unable to get to clinic	1	0	6	2
Overall Study Withdrew consent	0	1	1	3
Overall Study Not willing to adhere to study reqs	2	0	2	2
Overall Study Clinic unable to contact subject	3	3	1	1

Baseline Characteristics

Antiviral Responses to NNRTI-Based vs. PI-Based ARV Therapy in HIV Infected Infants Who Have or Have Not Received Single Dose NVP for Prevention of Mother-to-Child Transmission of HIV

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Coh I: NVP n=82 Participants Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.	Coh I: LPV/r n=82 Participants Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.	Coh II: NVP n=147 Participants Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen	Coh II: LPV/r n=140 Participants Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen	Total n=451 Participants Total of all reporting groups
Age, Customized <12 months	60 participants n=93 Participants	63 participants n=4 Participants	41 participants n=27 Participants	36 participants n=483 Participants	200 participants n=36 Participants
Age, Customized >=12 months	22 participants n=93 Participants	19 participants n=4 Participants	106 participants n=27 Participants	104 participants n=483 Participants	251 participants n=36 Participants
Sex: Female, Male Female	46 Participants n=93 Participants	41 Participants n=4 Participants	78 Participants n=27 Participants	72 Participants n=483 Participants	237 Participants n=36 Participants
Sex: Female, Male Male	36 Participants n=93 Participants	41 Participants n=4 Participants	69 Participants n=27 Participants	68 Participants n=483 Participants	214 Participants n=36 Participants
Race/Ethnicity, Customized Black African	81 participants n=93 Participants	81 participants n=4 Participants	132 participants n=27 Participants	134 participants n=483 Participants	428 participants n=36 Participants
Race/Ethnicity, Customized Coloured	1 participants n=93 Participants	1 participants n=4 Participants	1 participants n=27 Participants	2 participants n=483 Participants	5 participants n=36 Participants
Race/Ethnicity, Customized Native of India	0 participants n=93 Participants	0 participants n=4 Participants	12 participants n=27 Participants	4 participants n=483 Participants	16 participants n=36 Participants
Race/Ethnicity, Customized Not available	0 participants n=93 Participants	0 participants n=4 Participants	2 participants n=27 Participants	0 participants n=483 Participants	2 participants n=36 Participants
Region of Enrollment Tanzania	2 participants n=93 Participants	0 participants n=4 Participants	8 participants n=27 Participants	7 participants n=483 Participants	17 participants n=36 Participants
Region of Enrollment Zambia	2 participants n=93 Participants	4 participants n=4 Participants	14 participants n=27 Participants	18 participants n=483 Participants	38 participants n=36 Participants
Region of Enrollment Uganda	1 participants n=93 Participants	4 participants n=4 Participants	20 participants n=27 Participants	20 participants n=483 Participants	45 participants n=36 Participants
Region of Enrollment Malawi	2 participants n=93 Participants	0 participants n=4 Participants	16 participants n=27 Participants	20 participants n=483 Participants	38 participants n=36 Participants
Region of Enrollment South Africa	71 participants n=93 Participants	65 participants n=4 Participants	41 participants n=27 Participants	36 participants n=483 Participants	213 participants n=36 Participants
Region of Enrollment Zimbabwe	4 participants n=93 Participants	9 participants n=4 Participants	36 participants n=27 Participants	35 participants n=483 Participants	84 participants n=36 Participants
Region of Enrollment India	0 participants n=93 Participants	0 participants n=4 Participants	12 participants n=27 Participants	4 participants n=483 Participants	16 participants n=36 Participants
Ever breastfed Yes	15 participants n=93 Participants	19 participants n=4 Participants	118 participants n=27 Participants	115 participants n=483 Participants	267 participants n=36 Participants
Ever breastfed No	67 participants n=93 Participants	63 participants n=4 Participants	29 participants n=27 Participants	25 participants n=483 Participants	184 participants n=36 Participants
Documentation of SD NVP use at birth Born before NVP available/mother known to have HIV	0 participants n=93 Participants	0 participants n=4 Participants	116 participants n=27 Participants	104 participants n=483 Participants	220 participants n=36 Participants
Documentation of SD NVP use at birth Medical record review	62 participants n=93 Participants	63 participants n=4 Participants	10 participants n=27 Participants	12 participants n=483 Participants	147 participants n=36 Participants
Documentation of SD NVP use at birth Verbal evidence only	20 participants n=93 Participants	19 participants n=4 Participants	19 participants n=27 Participants	22 participants n=483 Participants	80 participants n=36 Participants
Documentation of SD NVP use at birth Found to have received SD NVP	0 participants n=93 Participants	0 participants n=4 Participants	2 participants n=27 Participants	2 participants n=483 Participants	4 participants n=36 Participants
WHO Stage I	7 participants n=93 Participants	18 participants n=4 Participants	29 participants n=27 Participants	25 participants n=483 Participants	79 participants n=36 Participants
WHO Stage II	23 participants n=93 Participants	22 participants n=4 Participants	26 participants n=27 Participants	27 participants n=483 Participants	98 participants n=36 Participants
WHO Stage III	39 participants n=93 Participants	38 participants n=4 Participants	80 participants n=27 Participants	77 participants n=483 Participants	234 participants n=36 Participants
WHO Stage IV	13 participants n=93 Participants	4 participants n=4 Participants	12 participants n=27 Participants	11 participants n=483 Participants	40 participants n=36 Participants
HIV-1 RNA <100,000 copies/ml	6 participants n=93 Participants	5 participants n=4 Participants	20 participants n=27 Participants	27 participants n=483 Participants	58 participants n=36 Participants
HIV-1 RNA 100,000 - < 750,000 copies/ml	27 participants n=93 Participants	34 participants n=4 Participants	70 participants n=27 Participants	53 participants n=483 Participants	184 participants n=36 Participants
HIV-1 RNA >=750,000 copies/ml	49 participants n=93 Participants	43 participants n=4 Participants	57 participants n=27 Participants	60 participants n=483 Participants	209 participants n=36 Participants
CD4 Percent <15 Percent	24 participants n=93 Participants	21 participants n=4 Participants	73 participants n=27 Participants	69 participants n=483 Participants	187 participants n=36 Participants
CD4 Percent 15 Percent - < 25 Percent	37 participants n=93 Participants	37 participants n=4 Participants	60 participants n=27 Participants	54 participants n=483 Participants	188 participants n=36 Participants
CD4 Percent >= 25 Percent	21 participants n=93 Participants	24 participants n=4 Participants	13 participants n=27 Participants	17 participants n=483 Participants	75 participants n=36 Participants
CD4 Percent Missing	0 participants n=93 Participants	0 participants n=4 Participants	1 participants n=27 Participants	0 participants n=483 Participants	1 participants n=36 Participants
NVP resistance Yes	7 participants n=93 Participants	11 participants n=4 Participants	1 participants n=27 Participants	4 participants n=483 Participants	23 participants n=36 Participants
NVP resistance No	68 participants n=93 Participants	62 participants n=4 Participants	110 participants n=27 Participants	91 participants n=483 Participants	331 participants n=36 Participants
NVP resistance Not available	7 participants n=93 Participants	9 participants n=4 Participants	36 participants n=27 Participants	45 participants n=483 Participants	97 participants n=36 Participants

PRIMARY outcome

Timeframe: Earlier of 24 weeks or date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009; Coh II: October 27, 2010)

Population: Analysis uses intent to treat population

Outcome measures

Outcome measures
Measure	Coh I: NVP n=82 Participants Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.	Coh I: LPV/r n=82 Participants Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.	Coh II: NVP n=147 Participants Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen	Coh II: LPV/r n=140 Participants Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
Percent of Participants With Treatment Failure, Defined as a Confirmed Virologic Failure or Permanent Discontinuation of the Randomized NNRTI or PI Component of Study Treatment	39.6 Percent of participants	21.7 Percent of participants	40.8 Percent of participants	19.3 Percent of participants

SECONDARY outcome

Timeframe: Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks)

Population: Analysis uses intent to treat population

Treatment failure is defined as a confirmed plasma HIV-1 RNA level that is \<1 log10 copies/mL below the study entry value at 12 to 24 weeks after treatment is initiated OR a confirmed plasma HIV-1 RNA level \>400 copies/mL at 24 weeks OR a confirmed viral rebound \>4000 copies/mL after week 24 OR permanent discontinuation of the randomized NNRTI or PI component of study treatment for any reason including death.

Outcome measures

Outcome measures
Measure	Coh I: NVP n=82 Participants Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.	Coh I: LPV/r n=82 Participants Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.	Coh II: NVP n=147 Participants Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen	Coh II: LPV/r n=140 Participants Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
Time From Randomization to Treatment Failure, Defined as Virologic Failure or Permanent Discontinuation of the Randomized NNRTI or PI Component of Study Treatment 10th percentile	12 Weeks Interval 4.0 to 12.0	4 Weeks Interval 4.0 to 16.0	4 Weeks Interval 2.0 to 8.0	14 Weeks Interval 8.0 to 24.0
Time From Randomization to Treatment Failure, Defined as Virologic Failure or Permanent Discontinuation of the Randomized NNRTI or PI Component of Study Treatment 25th percentile	16 Weeks Interval 12.0 to 24.0	36 Weeks Interval 16.0 to Not estimable as upper limit for survival function at all weeks is above 75%	16 Weeks Interval 12.0 to 24.0	36 Weeks Interval 24.0 to 108.0

SECONDARY outcome

Timeframe: Earlier of 24 weeks or date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009; Coh II: October 27, 2010)

Population: Analysis uses intent to treat population.

Virologic failure is defined as a confirmed plasma HIV-1 RNA level that is \<1 log10 copies/mL below the study entry value at 12 to 24 weeks after treatment is initiated OR a confirmed plasma HIV-1 RNA level \>400 copies/mL at 24 weeks OR death on or before 24 weeks. Results report percent of participants reaching a virologic failure endpoint by week 24 calculated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Coh I: NVP n=82 Participants Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.	Coh I: LPV/r n=82 Participants Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.	Coh II: NVP n=147 Participants Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen	Coh II: LPV/r n=140 Participants Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
Percent of Participants Experiencing Virologic Failure	27.4 Percent of participants	10.4 Percent of participants	28.6 Percent of participants	12.9 Percent of participants

SECONDARY outcome

Population: Analysis uses intent to treat population

Virologic failure is defined as the earlier of a confirmed plasma HIV-1 RNA level that is \<1 log10 copies/mL below the study entry value at 12 to 24 weeks after treatment is initiated OR a confirmed plasma HIV-1 RNA level \>400 copies/mL at 24 weeks OR a confirmed viral rebound \>4000 copies/mL after week 24 OR death.

Outcome measures

Outcome measures
Measure	Coh I: NVP n=82 Participants Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.	Coh I: LPV/r n=82 Participants Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.	Coh II: NVP n=147 Participants Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen	Coh II: LPV/r n=140 Participants Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
Time From Randomization to Virologic Failure 5th percentile	12 Weeks Interval 4.0 to 12.0	16 Weeks Interval 2.0 to 24.0	12 Weeks Interval 2.0 to 16.0	16 Weeks Interval 12.0 to 24.0
Time From Randomization to Virologic Failure 10th percentile	12 Weeks Interval 12.0 to 24.0	24 Weeks Interval 12.0 to Not estimable as upper limit for survival function at all weeks above 90%	16 Weeks Interval 12.0 to 24.0	24 Weeks Interval 16.0 to 36.0

SECONDARY outcome

Timeframe: On randomized NNRTI or PI component of study treatment and until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009; Coh II: October 27, 2010)

Population: Uses follow-up from start of NVP or LPV/r component of study treatment until component switched or date of DSMB decision to unblind results, whichever occurred first

Safety events include lab abnormalities, signs or symptoms of grade 3 or higher. Events were graded according to the Division of AIDS Table for Grading Severity of Adult and Pediatric Adverse Events, Version 1.0. Events defined as new if first occurrence was after initiation of study treatment or if severity increased from entry and while on the NNRTI or PI component of study treatment.

Outcome measures

Outcome measures
Measure	Coh I: NVP n=82 Participants Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.	Coh I: LPV/r n=82 Participants Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.	Coh II: NVP n=147 Participants Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen	Coh II: LPV/r n=140 Participants Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
Time From Start of Study Treatment to First New Grade >=3 Lab Abnormality, Sign or Symptom Occurring on Study Treatment 10th percentile	4 Weeks Interval 2.0 to 12.0	8 Weeks Interval 2.0 to 25.0	3 Weeks Interval 1.0 to 4.0	4 Weeks Interval 2.0 to 5.0
Time From Start of Study Treatment to First New Grade >=3 Lab Abnormality, Sign or Symptom Occurring on Study Treatment 25th percentile	24 Weeks Interval 12.0 to Not estimable as upper limit for survival function at all weeks above 75%	36 Weeks Interval 14.0 to 86.0	4 Weeks Interval 4.0 to 6.0	12 Weeks Interval 7.0 to 24.0

SECONDARY outcome

Population: Results included for any participant who was a virologic failure as defined in secondary outcome 4 and who had results available at study entry and virologic failure.

Numbers of participants developing new NRTI, NNRTI or PI-resistant virus after reaching a virologic failure endpoint

Outcome measures

Outcome measures
Measure	Coh I: NVP n=19 Participants Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.	Coh I: LPV/r n=5 Participants Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.	Coh II: NVP n=18 Participants Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen	Coh II: LPV/r n=7 Participants Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
Number of Participants Developing New NRTI, NNRTI or PI-resistant Virus	16 participants	1 participants	10 participants	4 participants

SECONDARY outcome

Timeframe: 48 weeks if before date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009; Coh II: October 27, 2010)

Population: Analysis uses intent to treat population. Change reported if subject followed at least 48 weeks before DSMB unblinding of results for each Cohort

Change was calculated as CD4 percent at week 48 minus entry CD4 percent (last CD4 percent before randomization date). Only subjects who reached 48 weeks of follow-up before DSMB decisions to unblind each Cohort were included in summary.

Outcome measures

Outcome measures
Measure	Coh I: NVP n=63 Participants Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.	Coh I: LPV/r n=70 Participants Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.	Coh II: NVP n=109 Participants Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen	Coh II: LPV/r n=119 Participants Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
Change in CD4 Percent From Entry to Week 48	13.9 Percent of CD4 Interval 11.6 to 16.2	12.0 Percent of CD4 Interval 10.3 to 13.7	15.2 Percent of CD4 Interval 13.6 to 16.9	14.3 Percent of CD4 Interval 13.0 to 15.7

SECONDARY outcome

Population: Analysis uses intent to treat population

HIV-related disease progression was defined as progression in WHO clinical stage from stage at entry or death. For subjects in WHO Stage IV at entry, disease progression was defined as death.

Outcome measures

Outcome measures
Measure	Coh I: NVP n=82 Participants Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.	Coh I: LPV/r n=82 Participants Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.	Coh II: NVP n=147 Participants Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen	Coh II: LPV/r n=140 Participants Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
Time From Randomization to HIV-related Disease Progression or Death 5th percentile	11 Weeks Interval 2.0 to 24.0	2 Weeks Interval 2.0 to 4.0	8 Weeks Interval 2.0 to 24.0	35 Weeks Interval 2.0 to 132.0
Time From Randomization to HIV-related Disease Progression or Death 10th percentile	17 Weeks Interval 5.0 to Not estimable as upper limit of survival function at all weeks above 90%	4 Weeks Interval 2.0 to 24.0	35 Weeks Interval 8.0 to Not estimable as upper limit of survival function at all weeks above 98%	132 Weeks Interval 35.0 to Not estimable as upper limit of survival function at all weeks above 98%

SECONDARY outcome

Population: Analysis uses intent to treat population

Results report 2nd percentile of time from randomization to death

Outcome measures

Outcome measures
Measure	Coh I: NVP n=82 Participants Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.	Coh I: LPV/r n=82 Participants Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.	Coh II: NVP n=147 Participants Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen	Coh II: LPV/r n=140 Participants Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
Time From Randomization to Death	11 Weeks Interval 3.0 to 68.0	3 Weeks Interval 2.0 to Not estimable as upper limit for survival function at all weeks above 98%	2 Weeks Interval 2.0 to 12.0	83 Weeks Interval 3.0 to Not estimable as upper limit for survival function at all weeks above 98%

Adverse Events

Coh I: NVP

Serious events: 23 serious events

Other events: 81 other events

Deaths: 6 deaths

Coh I: LPV/r

Serious events: 19 serious events

Other events: 82 other events

Deaths: 3 deaths

Coh II: NVP

Serious events: 65 serious events

Other events: 146 other events

Deaths: 10 deaths

Coh II: LPV/r

Serious events: 47 serious events

Other events: 140 other events

Deaths: 6 deaths

Serious adverse events

Other adverse events

Additional Information

Melissa Allen, Director, IMPAACT Operations Center

Family Health International (FHI 360)

Phone: (919) 405-1429

Email: [email protected]

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 manuscript 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

Serious adverse events
Measure	Coh I: NVP n=82 participants at risk Cohort II: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.	Coh I: LPV/r n=82 participants at risk Cohort II: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.	Coh II: NVP n=147 participants at risk Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen.	Coh II: LPV/r n=140 participants at risk Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen.
Blood and lymphatic system disorders Anaemia	1.2% 1/82 • From study enrollment until study completion 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.	1.2% 1/82 • From study enrollment until study completion 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.	2.0% 3/147 • From study enrollment until study completion 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.	3.6% 5/140 • From study enrollment until study completion 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.
Blood and lymphatic system disorders Neutropenia	14.6% 12/82 • From study enrollment until study completion 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.	13.4% 11/82 • From study enrollment until study completion 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.	16.3% 24/147 • From study enrollment until study completion 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.	16.4% 23/140 • From study enrollment until study completion 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.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/82 • From study enrollment until study completion 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.	0.00% 0/82 • From study enrollment until study completion 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.	0.68% 1/147 • From study enrollment until study completion 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.	1.4% 2/140 • From study enrollment until study completion 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 Diarrhoea	1.2% 1/82 • From study enrollment until study completion 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.	1.2% 1/82 • From study enrollment until study completion 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.	2.0% 3/147 • From study enrollment until study completion 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.	0.71% 1/140 • From study enrollment until study completion 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 Vomiting	0.00% 0/82 • From study enrollment until study completion 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.	0.00% 0/82 • From study enrollment until study completion 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.	0.00% 0/147 • From study enrollment until study completion 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.	0.71% 1/140 • From study enrollment until study completion 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 Death	2.4% 2/82 • From study enrollment until study completion 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.	2.4% 2/82 • From study enrollment until study completion 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.	1.4% 2/147 • From study enrollment until study completion 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.	0.71% 1/140 • From study enrollment until study completion 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 Pyrexia	0.00% 0/82 • From study enrollment until study completion 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.	0.00% 0/82 • From study enrollment until study completion 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.	0.68% 1/147 • From study enrollment until study completion 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.	0.00% 0/140 • From study enrollment until study completion 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.
Immune system disorders Immunosuppression	0.00% 0/82 • From study enrollment until study completion 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.	0.00% 0/82 • From study enrollment until study completion 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.	1.4% 2/147 • From study enrollment until study completion 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.	0.00% 0/140 • From study enrollment until study completion 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 Gastroenteritis	2.4% 2/82 • From study enrollment until study completion 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.	0.00% 0/82 • From study enrollment until study completion 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.	1.4% 2/147 • From study enrollment until study completion 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.	2.1% 3/140 • From study enrollment until study completion 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 Hepatitis A	0.00% 0/82 • From study enrollment until study completion 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.	0.00% 0/82 • From study enrollment until study completion 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.	0.68% 1/147 • From study enrollment until study completion 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.	0.00% 0/140 • From study enrollment until study completion 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 Malaria	0.00% 0/82 • From study enrollment until study completion 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.	0.00% 0/82 • From study enrollment until study completion 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.	4.1% 6/147 • From study enrollment until study completion 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.	4.3% 6/140 • From study enrollment until study completion 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 Measles	0.00% 0/82 • From study enrollment until study completion 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.	0.00% 0/82 • From study enrollment until study completion 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.	0.68% 1/147 • From study enrollment until study completion 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.	0.71% 1/140 • From study enrollment until study completion 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 Meningitis	0.00% 0/82 • From study enrollment until study completion 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.	0.00% 0/82 • From study enrollment until study completion 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.	0.68% 1/147 • From study enrollment until study completion 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.	0.00% 0/140 • From study enrollment until study completion 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	3.7% 3/82 • From study enrollment until study completion 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.	1.2% 1/82 • From study enrollment until study completion 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.	6.8% 10/147 • From study enrollment until study completion 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.	4.3% 6/140 • From study enrollment until study completion 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 Sepsis	2.4% 2/82 • From study enrollment until study completion 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.	0.00% 0/82 • From study enrollment until study completion 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.	0.68% 1/147 • From study enrollment until study completion 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.	0.00% 0/140 • From study enrollment until study completion 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 Injury	1.2% 1/82 • From study enrollment until study completion 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.	0.00% 0/82 • From study enrollment until study completion 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.	0.00% 0/147 • From study enrollment until study completion 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.	0.00% 0/140 • From study enrollment until study completion 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 abnormal	0.00% 0/82 • From study enrollment until study completion 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.	0.00% 0/82 • From study enrollment until study completion 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.	0.68% 1/147 • From study enrollment until study completion 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.	0.00% 0/140 • From study enrollment until study completion 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	1.2% 1/82 • From study enrollment until study completion 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.	1.2% 1/82 • From study enrollment until study completion 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.	2.7% 4/147 • From study enrollment until study completion 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.	0.00% 0/140 • From study enrollment until study completion 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 increased	0.00% 0/82 • From study enrollment until study completion 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.	1.2% 1/82 • From study enrollment until study completion 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.	0.00% 0/147 • From study enrollment until study completion 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.	0.00% 0/140 • From study enrollment until study completion 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 Haemoglobin decreased	1.2% 1/82 • From study enrollment until study completion 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.	0.00% 0/82 • From study enrollment until study completion 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.	0.68% 1/147 • From study enrollment until study completion 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.	1.4% 2/140 • From study enrollment until study completion 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 Hepatic enzyme increased	0.00% 0/82 • From study enrollment until study completion 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.	0.00% 0/82 • From study enrollment until study completion 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.	0.68% 1/147 • From study enrollment until study completion 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.	0.71% 1/140 • From study enrollment until study completion 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	1.2% 1/82 • From study enrollment until study completion 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.	1.2% 1/82 • From study enrollment until study completion 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.	1.4% 2/147 • From study enrollment until study completion 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.	0.71% 1/140 • From study enrollment until study completion 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	1.2% 1/82 • From study enrollment until study completion 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.	1.2% 1/82 • From study enrollment until study completion 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.	6.1% 9/147 • From study enrollment until study completion 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.	2.1% 3/140 • From study enrollment until study completion 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 Transaminases increased	1.2% 1/82 • From study enrollment until study completion 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.	0.00% 0/82 • From study enrollment until study completion 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.	2.7% 4/147 • From study enrollment until study completion 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.	0.00% 0/140 • From study enrollment until study completion 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 Hypokalaemia	0.00% 0/82 • From study enrollment until study completion 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.	0.00% 0/82 • From study enrollment until study completion 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.	1.4% 2/147 • From study enrollment until study completion 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.	0.00% 0/140 • From study enrollment until study completion 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 Lactic acidosis	0.00% 0/82 • From study enrollment until study completion 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.	0.00% 0/82 • From study enrollment until study completion 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.	0.68% 1/147 • From study enrollment until study completion 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.	0.00% 0/140 • From study enrollment until study completion 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 Headache	0.00% 0/82 • From study enrollment until study completion 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.	0.00% 0/82 • From study enrollment until study completion 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.	0.00% 0/147 • From study enrollment until study completion 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.	0.71% 1/140 • From study enrollment until study completion 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 Hypocalcaemic seizure	0.00% 0/82 • From study enrollment until study completion 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.	0.00% 0/82 • From study enrollment until study completion 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.	0.68% 1/147 • From study enrollment until study completion 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.	0.00% 0/140 • From study enrollment until study completion 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 Breath holding	0.00% 0/82 • From study enrollment until study completion 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.	0.00% 0/82 • From study enrollment until study completion 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.	0.68% 1/147 • From study enrollment until study completion 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.	0.00% 0/140 • From study enrollment until study completion 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.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/82 • From study enrollment until study completion 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.	1.2% 1/82 • From study enrollment until study completion 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.	0.00% 0/147 • From study enrollment until study completion 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.	0.00% 0/140 • From study enrollment until study completion 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 Dermatitis	0.00% 0/82 • From study enrollment until study completion 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.	0.00% 0/82 • From study enrollment until study completion 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.	0.68% 1/147 • From study enrollment until study completion 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.	0.00% 0/140 • From study enrollment until study completion 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 Rash	0.00% 0/82 • From study enrollment until study completion 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.	0.00% 0/82 • From study enrollment until study completion 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.	0.68% 1/147 • From study enrollment until study completion 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.	0.00% 0/140 • From study enrollment until study completion 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	Coh I: NVP n=82 participants at risk Cohort II: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.	Coh I: LPV/r n=82 participants at risk Cohort II: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.	Coh II: NVP n=147 participants at risk Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen.	Coh II: LPV/r n=140 participants at risk Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen.
Blood and lymphatic system disorders Anaemia	0.00% 0/82 • From study enrollment until study completion 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.	1.2% 1/82 • From study enrollment until study completion 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.	6.1% 9/147 • From study enrollment until study completion 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.	0.71% 1/140 • From study enrollment until study completion 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.
Blood and lymphatic system disorders Iron deficiency anaemia	1.2% 1/82 • From study enrollment until study completion 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.	3.7% 3/82 • From study enrollment until study completion 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.	11.6% 17/147 • From study enrollment until study completion 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.	9.3% 13/140 • From study enrollment until study completion 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.
Blood and lymphatic system disorders Lymphadenopathy	2.4% 2/82 • From study enrollment until study completion 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.	2.4% 2/82 • From study enrollment until study completion 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.	12.9% 19/147 • From study enrollment until study completion 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.	11.4% 16/140 • From study enrollment until study completion 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.
Blood and lymphatic system disorders Neutropenia	3.7% 3/82 • From study enrollment until study completion 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.	3.7% 3/82 • From study enrollment until study completion 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.	12.2% 18/147 • From study enrollment until study completion 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.	11.4% 16/140 • From study enrollment until study completion 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.
Ear and labyrinth disorders Otorrhoea	3.7% 3/82 • From study enrollment until study completion 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.	0.00% 0/82 • From study enrollment until study completion 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.	8.2% 12/147 • From study enrollment until study completion 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.	2.9% 4/140 • From study enrollment until study completion 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.
Eye disorders Eye discharge	2.4% 2/82 • From study enrollment until study completion 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.	3.7% 3/82 • From study enrollment until study completion 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.	12.9% 19/147 • From study enrollment until study completion 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.	9.3% 13/140 • From study enrollment until study completion 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.
Eye disorders Eye pruritus	0.00% 0/82 • From study enrollment until study completion 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.	0.00% 0/82 • From study enrollment until study completion 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.	5.4% 8/147 • From study enrollment until study completion 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.	2.1% 3/140 • From study enrollment until study completion 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.
Eye disorders Ocular hyperaemia	1.2% 1/82 • From study enrollment until study completion 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.	3.7% 3/82 • From study enrollment until study completion 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.	12.9% 19/147 • From study enrollment until study completion 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.	14.3% 20/140 • From study enrollment until study completion 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 Abdominal pain	1.2% 1/82 • From study enrollment until study completion 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.	3.7% 3/82 • From study enrollment until study completion 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.	10.9% 16/147 • From study enrollment until study completion 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.	9.3% 13/140 • From study enrollment until study completion 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 Aphthous ulcer	1.2% 1/82 • From study enrollment until study completion 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.	4.9% 4/82 • From study enrollment until study completion 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.	4.8% 7/147 • From study enrollment until study completion 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.	8.6% 12/140 • From study enrollment until study completion 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 Diarrhoea	15.9% 13/82 • From study enrollment until study completion 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.	19.5% 16/82 • From study enrollment until study completion 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.	34.0% 50/147 • From study enrollment until study completion 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.	33.6% 47/140 • From study enrollment until study completion 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 Stomatitis	1.2% 1/82 • From study enrollment until study completion 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.	3.7% 3/82 • From study enrollment until study completion 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.	5.4% 8/147 • From study enrollment until study completion 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.	8.6% 12/140 • From study enrollment until study completion 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 Vomiting	8.5% 7/82 • From study enrollment until study completion 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.	7.3% 6/82 • From study enrollment until study completion 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.	31.3% 46/147 • From study enrollment until study completion 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.	23.6% 33/140 • From study enrollment until study completion 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 Peripheral swelling	2.4% 2/82 • From study enrollment until study completion 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.	1.2% 1/82 • From study enrollment until study completion 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.	3.4% 5/147 • From study enrollment until study completion 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.	5.7% 8/140 • From study enrollment until study completion 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 Pyrexia	15.9% 13/82 • From study enrollment until study completion 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.	20.7% 17/82 • From study enrollment until study completion 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.	46.3% 68/147 • From study enrollment until study completion 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.	48.6% 68/140 • From study enrollment until study completion 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 Acarodermatitis	19.5% 16/82 • From study enrollment until study completion 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.	19.5% 16/82 • From study enrollment until study completion 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.	9.5% 14/147 • From study enrollment until study completion 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.	9.3% 13/140 • From study enrollment until study completion 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 Body tinea	14.6% 12/82 • From study enrollment until study completion 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.	12.2% 10/82 • From study enrollment until study completion 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.	22.4% 33/147 • From study enrollment until study completion 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.	22.1% 31/140 • From study enrollment until study completion 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 Bronchiolitis	4.9% 4/82 • From study enrollment until study completion 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.	6.1% 5/82 • From study enrollment until study completion 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.	8.2% 12/147 • From study enrollment until study completion 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.	5.7% 8/140 • From study enrollment until study completion 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	11.0% 9/82 • From study enrollment until study completion 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.	13.4% 11/82 • From study enrollment until study completion 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.	7.5% 11/147 • From study enrollment until study completion 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.	7.1% 10/140 • From study enrollment until study completion 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 Cellulitis	6.1% 5/82 • From study enrollment until study completion 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.	3.7% 3/82 • From study enrollment until study completion 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.	4.1% 6/147 • From study enrollment until study completion 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.	4.3% 6/140 • From study enrollment until study completion 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 Conjunctivitis	8.5% 7/82 • From study enrollment until study completion 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.	15.9% 13/82 • From study enrollment until study completion 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.	34.0% 50/147 • From study enrollment until study completion 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.	30.0% 42/140 • From study enrollment until study completion 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 Gastroenteritis	24.4% 20/82 • From study enrollment until study completion 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.	28.0% 23/82 • From study enrollment until study completion 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.	21.1% 31/147 • From study enrollment until study completion 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.	17.1% 24/140 • From study enrollment until study completion 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 Impetigo	20.7% 17/82 • From study enrollment until study completion 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.	25.6% 21/82 • From study enrollment until study completion 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.	17.7% 26/147 • From study enrollment until study completion 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.	14.3% 20/140 • From study enrollment until study completion 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 Malaria	6.1% 5/82 • From study enrollment until study completion 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.	6.1% 5/82 • From study enrollment until study completion 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.	22.4% 33/147 • From study enrollment until study completion 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.	32.1% 45/140 • From study enrollment until study completion 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 Measles	0.00% 0/82 • From study enrollment until study completion 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.	4.9% 4/82 • From study enrollment until study completion 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.	7.5% 11/147 • From study enrollment until study completion 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.	1.4% 2/140 • From study enrollment until study completion 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 Molluscum contagiosum	4.9% 4/82 • From study enrollment until study completion 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.	6.1% 5/82 • From study enrollment until study completion 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.	2.7% 4/147 • From study enrollment until study completion 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.	3.6% 5/140 • From study enrollment until study completion 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 Oral candidiasis	25.6% 21/82 • From study enrollment until study completion 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.	24.4% 20/82 • From study enrollment until study completion 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.	21.8% 32/147 • From study enrollment until study completion 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.	15.7% 22/140 • From study enrollment until study completion 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 Oral herpes	8.5% 7/82 • From study enrollment until study completion 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.	2.4% 2/82 • From study enrollment until study completion 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.	12.2% 18/147 • From study enrollment until study completion 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.	7.9% 11/140 • From study enrollment until study completion 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 Otitis externa	6.1% 5/82 • From study enrollment until study completion 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.	0.00% 0/82 • From study enrollment until study completion 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.	8.2% 12/147 • From study enrollment until study completion 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.	7.9% 11/140 • From study enrollment until study completion 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 Otitis media	18.3% 15/82 • From study enrollment until study completion 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.	20.7% 17/82 • From study enrollment until study completion 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.	25.9% 38/147 • From study enrollment until study completion 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.	19.3% 27/140 • From study enrollment until study completion 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 Otitis media acute	17.1% 14/82 • From study enrollment until study completion 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.	11.0% 9/82 • From study enrollment until study completion 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.	17.0% 25/147 • From study enrollment until study completion 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.	7.1% 10/140 • From study enrollment until study completion 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 Parotitis	2.4% 2/82 • From study enrollment until study completion 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.	0.00% 0/82 • From study enrollment until study completion 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.	3.4% 5/147 • From study enrollment until study completion 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.	5.7% 8/140 • From study enrollment until study completion 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 Persistent generalised lymphadenopathy	1.2% 1/82 • From study enrollment until study completion 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.	3.7% 3/82 • From study enrollment until study completion 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.	10.2% 15/147 • From study enrollment until study completion 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.	11.4% 16/140 • From study enrollment until study completion 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 Pharyngitis	20.7% 17/82 • From study enrollment until study completion 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.	17.1% 14/82 • From study enrollment until study completion 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.	21.8% 32/147 • From study enrollment until study completion 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.	17.9% 25/140 • From study enrollment until study completion 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 Plasmodium falciparum infection	3.7% 3/82 • From study enrollment until study completion 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.	3.7% 3/82 • From study enrollment until study completion 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.	23.1% 34/147 • From study enrollment until study completion 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.	27.9% 39/140 • From study enrollment until study completion 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	22.0% 18/82 • From study enrollment until study completion 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.	23.2% 19/82 • From study enrollment until study completion 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.	28.6% 42/147 • From study enrollment until study completion 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.	24.3% 34/140 • From study enrollment until study completion 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 bacterial	2.4% 2/82 • From study enrollment until study completion 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.	13.4% 11/82 • From study enrollment until study completion 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.	18.4% 27/147 • From study enrollment until study completion 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.	15.7% 22/140 • From study enrollment until study completion 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 Pulmonary tuberculosis	14.6% 12/82 • From study enrollment until study completion 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.	18.3% 15/82 • From study enrollment until study completion 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.	10.2% 15/147 • From study enrollment until study completion 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.	3.6% 5/140 • From study enrollment until study completion 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 Purulent discharge	1.2% 1/82 • From study enrollment until study completion 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.	1.2% 1/82 • From study enrollment until study completion 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.	4.8% 7/147 • From study enrollment until study completion 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.	5.7% 8/140 • From study enrollment until study completion 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 Subcutaneous abscess	2.4% 2/82 • From study enrollment until study completion 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.	6.1% 5/82 • From study enrollment until study completion 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.	2.0% 3/147 • From study enrollment until study completion 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.	4.3% 6/140 • From study enrollment until study completion 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.