Trial Outcomes & Findings for Daily Isoniazid to Prevent Tuberculosis in Infants Born to Mothers With HIV (NCT NCT00080119)

Last Updated: 2019-02-05

Results Overview

Criteria for diagnosis with TB disease: Definite-isolation of Mycobacterium TB (M.tb) or +ve stain on cerebrospinal fluid (CSF); Probable- +ve acid fast bacilli (AFB) stain on fluids/tissues other than CSF and sufficient clinical criteria/radiographic evidence suggestive of TB; Possible-abnormal chest radiograph suggestive of pulmonary TB (PTB) and either a +ve tuberculin skin test (TST) or minimum score on algorithm for clinical TB. Records reviewed by Endpoint Review Group. Results report percent of participants reaching TB disease/death by week 96 calculated using the Kaplan-Meier method.

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

1354 participants

Primary outcome timeframe

Through to week 96

Results posted on

2019-02-05

Participant Flow

Study participants were recruited at four study sites, three in South Africa and one in Botswana, between December 13, 2004 and June 26, 2008

Infants perinatally exposed to HIV 91-120 days with documented receipt of Bacille Calmette-Guerin (BCG) vaccine by 30 days (\>=90 days since receipt), no previous diagnosis or treatment of TB or contact with known TB case, stratified by HIV and randomized to receive blinded INH or INH placebo. 3 participants randomized but did not start treatment.

Participant milestones

Participant milestones
Measure	HIVneg/INH Perinatally exposed, HIV-uninfected (HIVneg) children receiving Isoniazid (INH)10-20 mg/kg orally once a day for 96 weeks + Trimethoprim/Sulfamethoxazole (TMP/SMX) 5 mg/kg of TMP component orally once a day until HIV status is confirmed and child is no longer at risk of acquiring HIV through breastfeeding	HIVneg/PL Perinatally-exposed, HIV-uninfected (HIVneg) children receiving Isoniazid placebo (PL) orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until HIV status is confirmed and child is no longer at risk of acquiring HIV through breastfeeding	HIVpos/INH HIV-infected (HIVpos) children receiving Isoniazid (INH) 10-20 mg/kg orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until one year of age. TMP/SMX may have been continued after one year of age according to WHO guidelines.	HIVpos/PL HIV-infected (HIVpos) children receiving Isoniazid placebo (PL) orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until one year of age. TMP/SMX may have been continued after one year of age according to WHO guidelines.
Overall Study STARTED	403	401	273	274
Overall Study COMPLETED	347	339	108	111
Overall Study NOT COMPLETED	56	62	165	163

Reasons for withdrawal

Reasons for withdrawal
Measure	HIVneg/INH Perinatally exposed, HIV-uninfected (HIVneg) children receiving Isoniazid (INH)10-20 mg/kg orally once a day for 96 weeks + Trimethoprim/Sulfamethoxazole (TMP/SMX) 5 mg/kg of TMP component orally once a day until HIV status is confirmed and child is no longer at risk of acquiring HIV through breastfeeding	HIVneg/PL Perinatally-exposed, HIV-uninfected (HIVneg) children receiving Isoniazid placebo (PL) orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until HIV status is confirmed and child is no longer at risk of acquiring HIV through breastfeeding	HIVpos/INH HIV-infected (HIVpos) children receiving Isoniazid (INH) 10-20 mg/kg orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until one year of age. TMP/SMX may have been continued after one year of age according to WHO guidelines.	HIVpos/PL HIV-infected (HIVpos) children receiving Isoniazid placebo (PL) orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until one year of age. TMP/SMX may have been continued after one year of age according to WHO guidelines.
Overall Study Discontinued because of study closure	0	0	130	141
Overall Study Unable to get to clinic	24	24	7	1
Overall Study Consent withdrawn	13	17	4	6
Overall Study Unwilling to adhere to study requirement	3	2	5	1
Overall Study Lost to Follow-up	16	19	19	14

Baseline Characteristics

Daily Isoniazid to Prevent Tuberculosis in Infants Born to Mothers With HIV

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HIVneg/INH n=403 Participants Perinatally exposed, HIV-uninfected (HIVneg) children receiving Isoniazid (INH)10-20 mg/kg orally once a day for 96 weeks + Trimethoprim/Sulfamethoxazole (TMP/SMX) 5 mg/kg of TMP component orally once a day until HIV status is confirmed and child is no longer at risk of acquiring HIV through breastfeeding	HIVneg/PL n=401 Participants Perinatally-exposed, HIV-uninfected (HIVneg) children receiving Isoniazid placebo (PL) orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until HIV status is confirmed and child is no longer at risk of acquiring HIV through breastfeeding	HIVpos/INH n=273 Participants HIV-infected (HIVpos) children receiving Isoniazid (INH) 10-20 mg/kg orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until one year of age. TMP/SMX may have been continued after one year of age according to WHO guidelines.	HIVpos/PL n=274 Participants HIV-infected (HIVpos) children receiving Isoniazid placebo (PL) orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until one year of age. TMP/SMX may have been continued after one year of age according to WHO guidelines.	Total n=1351 Participants Total of all reporting groups
Age, Customized 91-100 days	258 participants n=5 Participants	253 participants n=7 Participants	171 participants n=5 Participants	192 participants n=4 Participants	874 participants n=21 Participants
Age, Customized 101-110 days	71 participants n=5 Participants	84 participants n=7 Participants	56 participants n=5 Participants	33 participants n=4 Participants	244 participants n=21 Participants
Age, Customized 111-120 days	74 participants n=5 Participants	64 participants n=7 Participants	46 participants n=5 Participants	49 participants n=4 Participants	233 participants n=21 Participants
Sex: Female, Male Female	203 Participants n=5 Participants	190 Participants n=7 Participants	159 Participants n=5 Participants	151 Participants n=4 Participants	703 Participants n=21 Participants
Sex: Female, Male Male	200 Participants n=5 Participants	211 Participants n=7 Participants	114 Participants n=5 Participants	123 Participants n=4 Participants	648 Participants n=21 Participants
Race/Ethnicity, Customized Indigenous African	389 participants n=5 Participants	386 participants n=7 Participants	264 participants n=5 Participants	272 participants n=4 Participants	1311 participants n=21 Participants
Race/Ethnicity, Customized Mixed ancestry/other	14 participants n=5 Participants	15 participants n=7 Participants	9 participants n=5 Participants	2 participants n=4 Participants	40 participants n=21 Participants
Age at receipt of Bacille Calmette-Guerin (BCG) vaccination (days) <= 7 days	395 participants n=5 Participants	392 participants n=7 Participants	255 participants n=5 Participants	258 participants n=4 Participants	1300 participants n=21 Participants
Age at receipt of Bacille Calmette-Guerin (BCG) vaccination (days) 8-29 days	8 participants n=5 Participants	9 participants n=7 Participants	18 participants n=5 Participants	16 participants n=4 Participants	51 participants n=21 Participants
Any smoker in household Yes	191 participants n=5 Participants	177 participants n=7 Participants	120 participants n=5 Participants	131 participants n=4 Participants	619 participants n=21 Participants
Any smoker in household No	211 participants n=5 Participants	224 participants n=7 Participants	153 participants n=5 Participants	141 participants n=4 Participants	729 participants n=21 Participants
Any smoker in household Missing	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	2 participants n=4 Participants	3 participants n=21 Participants
Birth weight (grams) <2500 grams	49 participants n=5 Participants	49 participants n=7 Participants	68 participants n=5 Participants	56 participants n=4 Participants	222 participants n=21 Participants
Birth weight (grams) >= 2500 grams	354 participants n=5 Participants	352 participants n=7 Participants	205 participants n=5 Participants	218 participants n=4 Participants	1129 participants n=21 Participants
CD4% <20%	0 participants n=5 Participants	0 participants n=7 Participants	56 participants n=5 Participants	55 participants n=4 Participants	111 participants n=21 Participants
CD4% 20%-<25%	0 participants n=5 Participants	0 participants n=7 Participants	40 participants n=5 Participants	46 participants n=4 Participants	86 participants n=21 Participants
CD4% >= 25%	0 participants n=5 Participants	0 participants n=7 Participants	162 participants n=5 Participants	157 participants n=4 Participants	319 participants n=21 Participants
CD4% Missing	0 participants n=5 Participants	0 participants n=7 Participants	14 participants n=5 Participants	13 participants n=4 Participants	27 participants n=21 Participants
CD4% Not applicable	403 participants n=5 Participants	401 participants n=7 Participants	1 participants n=5 Participants	3 participants n=4 Participants	808 participants n=21 Participants
Centers for Disease Control (CDC) Disease Category Category N or A	0 participants n=5 Participants	0 participants n=7 Participants	252 participants n=5 Participants	244 participants n=4 Participants	496 participants n=21 Participants
Centers for Disease Control (CDC) Disease Category Category B	0 participants n=5 Participants	0 participants n=7 Participants	16 participants n=5 Participants	21 participants n=4 Participants	37 participants n=21 Participants
Centers for Disease Control (CDC) Disease Category Category C	0 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants	3 participants n=4 Participants	5 participants n=21 Participants
Centers for Disease Control (CDC) Disease Category HIV-uninfected on repeat test	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	3 participants n=4 Participants	4 participants n=21 Participants
Centers for Disease Control (CDC) Disease Category Missing	0 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants	3 participants n=4 Participants	5 participants n=21 Participants
Centers for Disease Control (CDC) Disease Category Not applicable (HIV-uninfected)	403 participants n=5 Participants	401 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	804 participants n=21 Participants
Caregiver currently smokes Yes	11 participants n=5 Participants	25 participants n=7 Participants	16 participants n=5 Participants	10 participants n=4 Participants	62 participants n=21 Participants
Caregiver currently smokes No	392 participants n=5 Participants	376 participants n=7 Participants	257 participants n=5 Participants	264 participants n=4 Participants	1289 participants n=21 Participants
Ever breastfed Yes	24 participants n=5 Participants	24 participants n=7 Participants	37 participants n=5 Participants	36 participants n=4 Participants	121 participants n=21 Participants
Ever breastfed No	379 participants n=5 Participants	377 participants n=7 Participants	236 participants n=5 Participants	238 participants n=4 Participants	1230 participants n=21 Participants
HIV-1 RNA (copies/ml) <= 400 copies/ml	0 participants n=5 Participants	0 participants n=7 Participants	8 participants n=5 Participants	12 participants n=4 Participants	20 participants n=21 Participants
HIV-1 RNA (copies/ml) 401 - <20,000 copies/ml	0 participants n=5 Participants	0 participants n=7 Participants	36 participants n=5 Participants	51 participants n=4 Participants	87 participants n=21 Participants
HIV-1 RNA (copies/ml) 20,000 - < 750,000 copies/ml	0 participants n=5 Participants	0 participants n=7 Participants	91 participants n=5 Participants	86 participants n=4 Participants	177 participants n=21 Participants
HIV-1 RNA (copies/ml) >= 750,000 copies/ml	0 participants n=5 Participants	0 participants n=7 Participants	129 participants n=5 Participants	116 participants n=4 Participants	245 participants n=21 Participants
HIV-1 RNA (copies/ml) Missing	0 participants n=5 Participants	0 participants n=7 Participants	8 participants n=5 Participants	6 participants n=4 Participants	14 participants n=21 Participants
HIV-1 RNA (copies/ml) Not applicable	403 participants n=5 Participants	401 participants n=7 Participants	1 participants n=5 Participants	3 participants n=4 Participants	808 participants n=21 Participants
History of tuberculosis (TB) in mother Yes	33 participants n=5 Participants	25 participants n=7 Participants	14 participants n=5 Participants	25 participants n=4 Participants	97 participants n=21 Participants
History of tuberculosis (TB) in mother No	370 participants n=5 Participants	376 participants n=7 Participants	259 participants n=5 Participants	249 participants n=4 Participants	1254 participants n=21 Participants
Housing Formal (brick) house	235 participants n=5 Participants	233 participants n=7 Participants	162 participants n=5 Participants	183 participants n=4 Participants	813 participants n=21 Participants
Housing Informal (shack/wooden)	168 participants n=5 Participants	168 participants n=7 Participants	109 participants n=5 Participants	89 participants n=4 Participants	534 participants n=21 Participants
Housing Hostel	0 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants	0 participants n=4 Participants	2 participants n=21 Participants
Housing Missing	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	2 participants n=4 Participants	2 participants n=21 Participants
On antiretrovirals at entry Yes	0 participants n=5 Participants	0 participants n=7 Participants	78 participants n=5 Participants	93 participants n=4 Participants	171 participants n=21 Participants
On antiretrovirals at entry No	0 participants n=5 Participants	0 participants n=7 Participants	194 participants n=5 Participants	178 participants n=4 Participants	372 participants n=21 Participants
On antiretrovirals at entry Not applicable	403 participants n=5 Participants	401 participants n=7 Participants	1 participants n=5 Participants	3 participants n=4 Participants	808 participants n=21 Participants
Site of enrollment Johannesburg, S Africa	259 participants n=5 Participants	260 participants n=7 Participants	180 participants n=5 Participants	179 participants n=4 Participants	878 participants n=21 Participants
Site of enrollment Cape Town, S Africa	140 participants n=5 Participants	138 participants n=7 Participants	66 participants n=5 Participants	65 participants n=4 Participants	409 participants n=21 Participants
Site of enrollment Durban, S Africa	4 participants n=5 Participants	3 participants n=7 Participants	26 participants n=5 Participants	27 participants n=4 Participants	60 participants n=21 Participants
Site of enrollment Gaborone, Botswana	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	3 participants n=4 Participants	4 participants n=21 Participants

PRIMARY outcome

Timeframe: Through to week 96

Population: Includes HIVpos who started study treatment. Time from randomization to TB disease/death was calculated. Participants lost-to-follow-up (LTF) \<96 wks (+12wks) censored at the time of LTF. Participants in follow-up at 96 wks free of TB disease censored at 96 wks. Participants on study when study discontinued censored at discontinuation visit.

Outcome measures

Outcome measures
Measure	HIVpos/INH n=273 Participants	HIVpos/PL n=274 Participants	HIVpos/INH	HIVpos/PL
Time to Development of Tuberculosis (TB) Disease or Death Among HIV-infected Children	27.4 Percent of participants	28.9 Percent of participants	—	—

PRIMARY outcome

Timeframe: Through to week 96

Population: HIVneg who started study treatment were included. Time from randomization to first of TB infection/death was calculated. Participants lost-to-follow-up before 96 wks were censored at the time of loss-to-follow-up. Participants in follow-up at 96 weeks (+12 week window) who were free of TB infection were censored at 96 weeks (+12 week window).

Criteria for diagnosis with TB infection were outlined in the protocol. TB infection included TB disease (see primary outcome measure 1 for definition) and latent TB infection. Latent TB infection was diagnosed by a positive tuberculin skin test (TST) based on a purified protein derivative (PPD) performed at week 96. Participant records were reviewed by an Endpoint Review Group to verify that participants had met the criteria for TB infection. Results report percent of participants reaching TB infection or death by week 96 calculated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	HIVpos/INH n=403 Participants	HIVpos/PL n=401 Participants	HIVpos/INH	HIVpos/PL
Time From Randomization to Development of TB Infection or Death Among Perinatally Exposed, HIV-uninfected Children	10.9 Percent of participants	12.6 Percent of participants	—	—

SECONDARY outcome

Timeframe: Through to week 96

Population: HIVpos starting study treatment were included. Time from randomization to first of TB infection/death was calculated. Participants LTF \<96 weeks (+12 wk) censored at the time LTF. Participants in follow-up at 96 wks free of TB infection censored at 96 wks. Participants on study when study discontinued were censored at discontinuation visit.

Criteria for diagnosis with TB infection were outlined in the protocol. TB infection included TB disease (see primary outcome measure 1 for definition) and latent TB infection. Latent TB infection was diagnosed by a positive TST based on a PPD performed at week 96. Participant records were reviewed by an Endpoint Review Group to verify that participants had met the criteria for TB infection. Results report percent of participants reaching TB infection or death by week 96 calculated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	HIVpos/INH n=273 Participants	HIVpos/PL n=274 Participants	HIVpos/INH	HIVpos/PL
Time From Randomization to Development of TB Infection or Death Among HIV-infected Children	29.4 Percent of participants	32.8 Percent of participants	—	—

SECONDARY outcome

Timeframe: Through to week 96

Population: Includes HIVpos starting study treatment. Time from randomization to first of disease progression/death calculated. Censored if LTF \<96 wks, at 96 wks (if on study) or at discontinuation visit. Participants found to be HIVneg upon repeat testing could only progress by meeting a death endpoint.

HIV disease progression was defined as any advancement in Centers for Disease Control (CDC) disease category from entry or death. If a participant was CDC disease category C at entry progression was defined as death. Results report percent of participants with HIV progression or death by week 96 calculated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	HIVpos/INH n=273 Participants	HIVpos/PL n=274 Participants	HIVpos/INH	HIVpos/PL
Time From Randomization to HIV Disease Progression or Death Among HIV-infected Children	30.6 Percent of participants	22.5 Percent of participants	—	—

SECONDARY outcome

Timeframe: Through to week 96

Population: Includes HIVneg who started study treatment. Time from randomization to the first of TB disease/death was calculated. Participants lost-to-follow-up before 96 weeks (+12 week window)were censored at the time of loss-to-follow-up. Participants in follow-up at 96 weeks who were free of TB disease were censored at 96 weeks (+12 week window).

Criteria for diagnosis with TB disease were: Definite-isolation of M.tb or positive stain on CSF; Probable-positive AFB stain on fluids/tissues other than CSF and sufficient clinical criteria/radiographic evidence suggestive of TB; Possible-abnormal chest radiograph suggestive of PTB and either a +ve TST or minimum score on algorithm to diagnose clinical TB. All records were reviewed by an Endpoint Review Group to verify that participants had met the criteria for TB disease. Results report percent of participants reaching TB disease/death by week 96 calculated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	HIVpos/INH n=403 Participants	HIVpos/PL n=401 Participants	HIVpos/INH	HIVpos/PL
Time From Randomization to Development of TB Disease or Death Among Perinatally Exposed, HIV-uninfected Children	8.3 Percent of participants	9.1 Percent of participants	—	—

SECONDARY outcome

Timeframe: Through to week 96

Population: Includes all starting study treatment. Time from randomization to development of TB disease was calculated. Participants LTF \<96 wks (+12 wks) censored at time of LTF. Participants in follow-up at 96 wks free of TB disease censored at 96 wks. HIVpos on study when study discontinued were censored at their discontinuation visit.

Outcome measures

Outcome measures
Measure	HIVpos/INH n=403 Participants	HIVpos/PL n=401 Participants	HIVpos/INH n=273 Participants	HIVpos/PL n=274 Participants
Time From Randomization to Development of TB Disease Among HIV Infected and Perinatally Exposed, HIV-uninfected Children	7.8 Percent of participants	8.5 Percent of participants	20.3 Percent of participants	23.7 Percent of participants

SECONDARY outcome

Timeframe: Through to week 96

Population: Includes all starting study treatment. Time from randomization to development of TB infection was calculated. Participants LTF \<96 weeks (+12 wks) censored at the time of LTF. Participants in follow-up at 96 wks free of TB infection were censored at 96 wks. HIVpos on study when study discontinued censored at their discontinuation visit.

Criteria for diagnosis with TB infection were outlined in the protocol. TB infection included TB disease (see primary outcome measure 1 for definition) and latent TB infection. Latent TB infection was diagnosed by a positive TST based on a PPD performed at week 96. Participant records were reviewed by an Endpoint Review Group to verify that participants had met the criteria for TB infection. Results report percent of participants reaching TB infection by week 96 calculated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	HIVpos/INH n=403 Participants	HIVpos/PL n=401 Participants	HIVpos/INH n=273 Participants	HIVpos/PL n=274 Participants
Time From Randomization to Development of TB Infection Among HIV-infected and Perinatally Exposed, HIV-uninfected Children	10.4 Percent of participants	12.1 Percent of participants	22.4 Percent of participants	27.9 Percent of participants

SECONDARY outcome

Timeframe: Through to week 96

Population: Includes all starting study treatment. Time from randomization to death was calculated. Participants LTF \<96 weeks (+12 wks) censored at the time of LTF. Participants in follow-up at 96 wks (+12 wks) censored at 96 weeks. HIVpos on study when study was discontinued were censored at their discontinuation visit.

Deaths from any cause were included. Results report percent of participants dying by week 96 calculated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	HIVpos/INH n=403 Participants	HIVpos/PL n=401 Participants	HIVpos/INH n=273 Participants	HIVpos/PL n=274 Participants
Time From Randomization to Death Among HIV-infected and Perinatally Exposed, HIV-uninfected Children	0.8 Percent of participants	0.8 Percent of participants	11.6 Percent of participants	7.2 Percent of participants

SECONDARY outcome

Timeframe: Through to week 96

Population: Includes all starting treatment. Time from randomization to first new adverse event (AE) calculated. For lab toxicities, censored at visit following permanent discontinuation of study drugs. For signs/symptoms, participants in follow-up at 96 wks (+12) with no new grade \>=3 AE censored at 96 wks. Participants LTF \<96 wks censored at LTF.

Signs, symptoms and laboratory values were graded according to the Division of AIDS Adverse Event Grading System. Any event of grade 3 or higher not present at entry that occurred after randomization was classified as a new event. Results report percent of participants with a new event by week 96 calculated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	HIVpos/INH n=403 Participants	HIVpos/PL n=401 Participants	HIVpos/INH n=273 Participants	HIVpos/PL n=274 Participants
Time From Randomization to First New Grade 3 or Worse Adverse Event Among HIV-infected and Perinatally Exposed, HIV-uninfected Children New >= grade 3 peripheral neuropathy	1.1 Percent of participants	0.3 Percent of participants	2.4 Percent of participants	0.8 Percent of participants
Time From Randomization to First New Grade 3 or Worse Adverse Event Among HIV-infected and Perinatally Exposed, HIV-uninfected Children New >=grade 3 sign/symptom	5.0 Percent of participants	4.2 Percent of participants	16.8 Percent of participants	11.7 Percent of participants
Time From Randomization to First New Grade 3 or Worse Adverse Event Among HIV-infected and Perinatally Exposed, HIV-uninfected Children New >=grade 3 lab abnormality	4.9 Percent of participants	4.6 Percent of participants	11.3 Percent of participants	10.1 Percent of participants
Time From Randomization to First New Grade 3 or Worse Adverse Event Among HIV-infected and Perinatally Exposed, HIV-uninfected Children New >=grade 3 hemoglobin	0.0 Percent of participants	0.0 Percent of participants	1.8 Percent of participants	1.2 Percent of participants
Time From Randomization to First New Grade 3 or Worse Adverse Event Among HIV-infected and Perinatally Exposed, HIV-uninfected Children New >=grade 3 ANC	1.7 Percent of participants	0.3 Percent of participants	1.6 Percent of participants	3.5 Percent of participants
Time From Randomization to First New Grade 3 or Worse Adverse Event Among HIV-infected and Perinatally Exposed, HIV-uninfected Children New >=grade 3 platelets	0.3 Percent of participants	0.0 Percent of participants	1.7 Percent of participants	0.9 Percent of participants
Time From Randomization to First New Grade 3 or Worse Adverse Event Among HIV-infected and Perinatally Exposed, HIV-uninfected Children New >=grade 3 SGOT	1.0 Percent of participants	2.8 Percent of participants	0.4 Percent of participants	2.5 Percent of participants
Time From Randomization to First New Grade 3 or Worse Adverse Event Among HIV-infected and Perinatally Exposed, HIV-uninfected Children New >=grade 3 SGPT	2.8 Percent of participants	4.4 Percent of participants	5.9 Percent of participants	4.0 Percent of participants

Adverse Events

HIVneg/INH

Serious events: 25 serious events

Other events: 353 other events

Deaths: 0 deaths

HIVneg/PL

Serious events: 18 serious events

Other events: 368 other events

Deaths: 0 deaths

HIVpos/INH

Serious events: 55 serious events

Other events: 264 other events

Deaths: 0 deaths

HIVpos/PL

Serious events: 42 serious events

Other events: 268 other events

Deaths: 0 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 manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	HIVneg/INH n=403 participants at risk Perinatally exposed, HIV-uninfected (HIVneg) children receiving Isoniazid (INH)10-20 mg/kg orally once a day for 96 weeks + Trimethoprim/Sulfamethoxazole (TMP/SMX) 5 mg/kg of TMP component orally once a day until HIV status is confirmed and child is no longer at risk of acquiring HIV through breastfeeding	HIVneg/PL n=401 participants at risk Perinatally-exposed, HIV-uninfected (HIVneg) children receiving Isoniazid placebo (PL) orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until HIV status is confirmed and child is no longer at risk of acquiring HIV through breastfeeding	HIVpos/INH n=273 participants at risk HIV-infected (HIVpos) children receiving Isoniazid (INH) 10-20 mg/kg orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until one year of age. TMP/SMX may have been continued after one year of age according to WHO guidelines.	HIVpos/PL n=274 participants at risk HIV-infected (HIVpos) children receiving Isoniazid placebo (PL) orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until one year of age. TMP/SMX may have been continued after one year of age according to WHO guidelines.
Blood and lymphatic system disorders Anaemia	0.00% 0/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	0.73% 2/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	0.36% 1/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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	0.25% 1/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	1.8% 5/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	0.36% 1/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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 Pancytopenia	0.00% 0/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	0.36% 1/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	0.73% 2/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.
Cardiac disorders Cardiac failure	0.25% 1/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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 Visual acuity reduced	0.25% 1/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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	0.00% 0/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	0.36% 1/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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 Accidental death	0.25% 1/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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	0.25% 1/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	0.50% 2/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 8/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	2.2% 6/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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 Sudden infant death syndrome	0.00% 0/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	0.37% 1/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.
Hepatobiliary disorders Hepatic failure	0.00% 0/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	0.36% 1/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.
Hepatobiliary disorders Hepatotoxicity	1.5% 6/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 5/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	2.2% 6/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	2.2% 6/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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	0.00% 0/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	0.37% 1/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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 Bronchopneumonia	0.00% 0/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	0.37% 1/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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 Encephalitis viral	0.00% 0/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	0.37% 1/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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 Escherichia sepsis	0.00% 0/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	0.37% 1/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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	0.00% 0/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	0.25% 1/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	3.3% 9/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	2.2% 6/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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 HIV infection	0.00% 0/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	0.37% 1/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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 Infection	0.00% 0/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	0.37% 1/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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 Lobar pneumonia	0.00% 0/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	0.37% 1/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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	0.00% 0/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	2.2% 6/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	1.8% 5/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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 cytomegaloviral	0.00% 0/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	0.37% 1/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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 herpes viral	0.00% 0/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	0.25% 1/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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 necrotising	0.00% 0/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	0.36% 1/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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	0.00% 0/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	0.73% 2/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	0.36% 1/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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 Tuberculosis	0.00% 0/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	0.37% 1/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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 Tuberculosis of eye	0.00% 0/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	0.36% 1/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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 Drug toxicity	0.00% 0/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	0.36% 1/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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 Poisoning	0.00% 0/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	0.36% 1/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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	0.00% 0/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	0.25% 1/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	1.5% 4/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	0.73% 2/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.
Investigations Aspartate aminotransferase increased	0.00% 0/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	1.1% 3/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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	0.00% 0/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	0.36% 1/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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 Liver function test abnormal	0.00% 0/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	0.37% 1/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 5/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	1.5% 6/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	0.73% 2/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	0.73% 2/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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	0.50% 2/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	0.25% 1/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	0.73% 2/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	0.73% 2/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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 Failure to thrive	0.00% 0/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	0.37% 1/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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 Encephalopathy	0.25% 1/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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 Neuropathy peripheral	1.2% 5/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	0.25% 1/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	0.37% 1/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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 Status epilepticus	0.25% 1/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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 Aspiration	0.00% 0/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	0.37% 1/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 0/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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	HIVneg/INH n=403 participants at risk Perinatally exposed, HIV-uninfected (HIVneg) children receiving Isoniazid (INH)10-20 mg/kg orally once a day for 96 weeks + Trimethoprim/Sulfamethoxazole (TMP/SMX) 5 mg/kg of TMP component orally once a day until HIV status is confirmed and child is no longer at risk of acquiring HIV through breastfeeding	HIVneg/PL n=401 participants at risk Perinatally-exposed, HIV-uninfected (HIVneg) children receiving Isoniazid placebo (PL) orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until HIV status is confirmed and child is no longer at risk of acquiring HIV through breastfeeding	HIVpos/INH n=273 participants at risk HIV-infected (HIVpos) children receiving Isoniazid (INH) 10-20 mg/kg orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until one year of age. TMP/SMX may have been continued after one year of age according to WHO guidelines.	HIVpos/PL n=274 participants at risk HIV-infected (HIVpos) children receiving Isoniazid placebo (PL) orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until one year of age. TMP/SMX may have been continued after one year of age according to WHO guidelines.
Infections and infestations Bronchiolitis	9.9% 40/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 41/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	4.4% 12/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	4.4% 12/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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	6.0% 24/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 33/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	6.6% 18/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	4.0% 11/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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 Lymphadenitis	0.00% 0/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	0.25% 1/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 10/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 28/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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	4.0% 16/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	7.0% 28/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	6.6% 18/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 26/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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 AIDS encephalopathy	0.00% 0/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	0.25% 1/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	7.7% 21/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	8.8% 24/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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	5.5% 22/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	5.0% 20/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	3.3% 9/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	5.5% 15/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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	22.3% 90/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 104/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	29.7% 81/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	28.8% 79/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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	3.2% 13/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 11/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	19.8% 54/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	19.7% 54/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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	34.7% 140/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	40.4% 162/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	16.8% 46/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 53/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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	30.3% 122/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	32.7% 131/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	24.9% 68/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	23.0% 63/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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	2.7% 11/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	3.0% 12/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	12.1% 33/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 28/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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	9.7% 39/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 44/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	17.2% 47/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	17.2% 47/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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 Tonsilitis	24.6% 99/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	26.9% 108/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	15.0% 41/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	15.0% 41/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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 Upper respiratory tract infection	6.5% 26/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	9.0% 36/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	1.8% 5/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	1.5% 4/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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	30.8% 124/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	30.2% 121/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	47.6% 130/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	41.6% 114/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.
Investigations Aspartate aminotransferase increased	21.8% 88/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	23.4% 94/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	39.9% 109/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	31.4% 86/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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 Gamma-glutamyltransferase increased	2.2% 9/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 8/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	5.1% 14/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	2.6% 7/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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	17.4% 70/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	18.0% 72/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	64.5% 176/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	64.2% 176/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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	29.0% 117/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	24.9% 100/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	36.6% 100/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	38.3% 105/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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 Failure to thrive	12.7% 51/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 33/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	15.0% 41/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	15.3% 42/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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 Neuropathy peripheral	11.7% 47/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	12.5% 50/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	27.5% 75/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	31.8% 87/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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 Eczema	10.2% 41/403 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 41/401 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	23.8% 65/273 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, 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% 49/274 • From study enrollment until study completion and before May 25, 2009 (primary completion date) Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.