Trial Outcomes & Findings for Safety and Effectiveness of Emtricitabine, Efavirenz, and Didanosine in HIV Infected Children Who Have Taken Few or No Anti-HIV Drugs (NCT NCT00016718)

Last Updated: 2021-11-05

Results Overview

Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RCC website at (http://rcc.tech-res.com/). Adverse Events of Grade 3 or 4 laboratory abnormalities or signs and symptoms that were judged by the study team to be possibly or probably related to the study treatment. Comparisons between age groups were not required as per protocol.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

43 participants

Primary outcome timeframe

At study entry, weeks 2 and 4, every 4 weeks up to week 96 and every 6 weeks thereafter for Group 1 participants and at study entry, weeks 2 and 4, every 4 weeks up to week 144 and every 12 weeks thereafter for Groups 2 and 3

Results posted on

2021-11-05

Participant Flow

Participant milestones

Participant milestones
Measure	Age Group 1 90 days to \< 3 years of age, inclusive (FTC, EFV, ddI)	Age Group 2 3 years to 12 years of age, inclusive (FTC, EFV, ddI)	Age Group 3 13 years to 21 years of age, inclusive (FTC, EFV, ddI)
Overall Study STARTED	6	21	16
Overall Study COMPLETED	6	21	16
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Effectiveness of Emtricitabine, Efavirenz, and Didanosine in HIV Infected Children Who Have Taken Few or No Anti-HIV Drugs

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Age Group 1 n=6 Participants 90 days to \< 3 years of age, inclusive (FTC, EFV, ddI)	Age Group 2 n=21 Participants 3 years to 12 years of age, inclusive (FTC, EFV, ddI)	Age Group 3 n=16 Participants 13 years to 21 years of age, inclusive (FTC, EFV, ddI)	Total n=43 Participants Total of all reporting groups
Age, Continuous	0.5 years n=5 Participants	5.7 years n=7 Participants	17.5 years n=5 Participants	9.6 years n=4 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	11 Participants n=7 Participants	6 Participants n=5 Participants	21 Participants n=4 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	22 Participants n=4 Participants
Race/Ethnicity, Customized White non-Hispanic	0 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Race/Ethnicity, Customized Black non-Hispanic	4 Participants n=5 Participants	11 Participants n=7 Participants	12 Participants n=5 Participants	27 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic	2 Participants n=5 Participants	7 Participants n=7 Participants	2 Participants n=5 Participants	11 Participants n=4 Participants

PRIMARY outcome

Timeframe: At study entry, weeks 2 and 4, every 4 weeks up to week 96 and every 6 weeks thereafter for Group 1 participants and at study entry, weeks 2 and 4, every 4 weeks up to week 144 and every 12 weeks thereafter for Groups 2 and 3

Population: All Participant who enrolled in the study

Outcome measures

Outcome measures
Measure	Age Group 1 n=6 Participants 90 days to \< 3 years of age, inclusive (FTC, EFV, ddI)	Age Group 2 n=21 Participants 3 years to 12 years of age, inclusive (FTC, EFV, ddI)	Age Group 3 n=16 Participants 13 years to 21 years of age, inclusive (FTC, EFV, ddI)
Proportion of Participants Who Developed Grade 3 or 4 Adverse Events Attributed to the Study Treatment.	0.17 proportion of participants Interval 0.03 to 0.56	0.1 proportion of participants Interval 0.03 to 0.29	0.19 proportion of participants Interval 0.07 to 0.43

PRIMARY outcome

Timeframe: At week 16

Population: All Participant who enrolled in the study and with available HIV-RNA at week 16

Proportion was calculated as number of participants with HIV-1 RNA \<= 400 copies/ml relative to the number of participants with HIV-1 RNA measured at that time point.

Outcome measures

Outcome measures
Measure	Age Group 1 n=6 Participants 90 days to \< 3 years of age, inclusive (FTC, EFV, ddI)	Age Group 2 n=21 Participants 3 years to 12 years of age, inclusive (FTC, EFV, ddI)	Age Group 3 n=16 Participants 13 years to 21 years of age, inclusive (FTC, EFV, ddI)
Proportion of Participants With Suppression of HIV Viral Load to Less Than 400 Copies/ml at Week 16	0.83 proportion of participants Interval 0.36 to 0.99	0.86 proportion of participants Interval 0.64 to 0.97	0.81 proportion of participants Interval 0.54 to 0.96

PRIMARY outcome

Timeframe: At week 16

Population: All Participant who enrolled in the study and with available HIV-RNA at week 16

Proportion was calculated as number of participants with HIV-1 RNA \<= 50 copies/ml relative to the number of participants with HIV-1 RNA measured at that time point.

Outcome measures

Outcome measures
Measure	Age Group 1 n=6 Participants 90 days to \< 3 years of age, inclusive (FTC, EFV, ddI)	Age Group 2 n=21 Participants 3 years to 12 years of age, inclusive (FTC, EFV, ddI)	Age Group 3 n=16 Participants 13 years to 21 years of age, inclusive (FTC, EFV, ddI)
Proportion of Participants With Suppression of HIV Viral Load to Less Than 50 Copies/ml at Week 16	0.50 proportion of participants Interval 0.12 to 0.88	0.76 proportion of participants Interval 0.53 to 0.92	0.75 proportion of participants Interval 0.48 to 0.93

Adverse Events

Age Group 1

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Age Group 2

Serious events: 4 serious events

Other events: 21 other events

Deaths: 0 deaths

Age Group 3

Serious events: 5 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Age Group 1 n=6 participants at risk 90 days to 3 years of age, inclusive (FTC, EFV, ddI)	Age Group 2 n=21 participants at risk 3 years to 12 years of age, inclusive (FTC, EFV, ddI)	Age Group 3 n=16 participants at risk 13 years to 21 years of age, inclusive (FTC, EFV, ddI)
Gastrointestinal disorders Abdominal pain	0.00% 0/6 • At study entry, weeks 2 and 4, every 4 weeks up to week 96 and every 6 weeks thereafter for Group 1 participants and at study entry, weeks 2 and 4, every 4 weeks up to week 144 and every 12 weeks thereafter for Group 2 and 3 participants The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events .Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RCC website at (http://rcc.tech-res.com/).	0.00% 0/21 • At study entry, weeks 2 and 4, every 4 weeks up to week 96 and every 6 weeks thereafter for Group 1 participants and at study entry, weeks 2 and 4, every 4 weeks up to week 144 and every 12 weeks thereafter for Group 2 and 3 participants The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events .Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RCC website at (http://rcc.tech-res.com/).	6.2% 1/16 • At study entry, weeks 2 and 4, every 4 weeks up to week 96 and every 6 weeks thereafter for Group 1 participants and at study entry, weeks 2 and 4, every 4 weeks up to week 144 and every 12 weeks thereafter for Group 2 and 3 participants The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events .Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RCC website at (http://rcc.tech-res.com/).
Gastrointestinal disorders Diarrhoea	0.00% 0/6 • At study entry, weeks 2 and 4, every 4 weeks up to week 96 and every 6 weeks thereafter for Group 1 participants and at study entry, weeks 2 and 4, every 4 weeks up to week 144 and every 12 weeks thereafter for Group 2 and 3 participants The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events .Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RCC website at (http://rcc.tech-res.com/).	0.00% 0/21 • At study entry, weeks 2 and 4, every 4 weeks up to week 96 and every 6 weeks thereafter for Group 1 participants and at study entry, weeks 2 and 4, every 4 weeks up to week 144 and every 12 weeks thereafter for Group 2 and 3 participants The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events .Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RCC website at (http://rcc.tech-res.com/).	6.2% 1/16 • At study entry, weeks 2 and 4, every 4 weeks up to week 96 and every 6 weeks thereafter for Group 1 participants and at study entry, weeks 2 and 4, every 4 weeks up to week 144 and every 12 weeks thereafter for Group 2 and 3 participants The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events .Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RCC website at (http://rcc.tech-res.com/).
Investigations Blood creatine phosphokinase increased	0.00% 0/6 • At study entry, weeks 2 and 4, every 4 weeks up to week 96 and every 6 weeks thereafter for Group 1 participants and at study entry, weeks 2 and 4, every 4 weeks up to week 144 and every 12 weeks thereafter for Group 2 and 3 participants The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events .Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RCC website at (http://rcc.tech-res.com/).	0.00% 0/21 • At study entry, weeks 2 and 4, every 4 weeks up to week 96 and every 6 weeks thereafter for Group 1 participants and at study entry, weeks 2 and 4, every 4 weeks up to week 144 and every 12 weeks thereafter for Group 2 and 3 participants The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events .Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RCC website at (http://rcc.tech-res.com/).	12.5% 2/16 • At study entry, weeks 2 and 4, every 4 weeks up to week 96 and every 6 weeks thereafter for Group 1 participants and at study entry, weeks 2 and 4, every 4 weeks up to week 144 and every 12 weeks thereafter for Group 2 and 3 participants The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events .Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RCC website at (http://rcc.tech-res.com/).
Investigations Blood glucose decreased	0.00% 0/6 • At study entry, weeks 2 and 4, every 4 weeks up to week 96 and every 6 weeks thereafter for Group 1 participants and at study entry, weeks 2 and 4, every 4 weeks up to week 144 and every 12 weeks thereafter for Group 2 and 3 participants The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events .Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RCC website at (http://rcc.tech-res.com/).	4.8% 1/21 • At study entry, weeks 2 and 4, every 4 weeks up to week 96 and every 6 weeks thereafter for Group 1 participants and at study entry, weeks 2 and 4, every 4 weeks up to week 144 and every 12 weeks thereafter for Group 2 and 3 participants The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events .Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RCC website at (http://rcc.tech-res.com/).	0.00% 0/16 • At study entry, weeks 2 and 4, every 4 weeks up to week 96 and every 6 weeks thereafter for Group 1 participants and at study entry, weeks 2 and 4, every 4 weeks up to week 144 and every 12 weeks thereafter for Group 2 and 3 participants The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events .Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RCC website at (http://rcc.tech-res.com/).
Investigations Gamma-glutamyltransferase increased	16.7% 1/6 • At study entry, weeks 2 and 4, every 4 weeks up to week 96 and every 6 weeks thereafter for Group 1 participants and at study entry, weeks 2 and 4, every 4 weeks up to week 144 and every 12 weeks thereafter for Group 2 and 3 participants The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events .Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RCC website at (http://rcc.tech-res.com/).	0.00% 0/21 • At study entry, weeks 2 and 4, every 4 weeks up to week 96 and every 6 weeks thereafter for Group 1 participants and at study entry, weeks 2 and 4, every 4 weeks up to week 144 and every 12 weeks thereafter for Group 2 and 3 participants The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events .Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RCC website at (http://rcc.tech-res.com/).	0.00% 0/16 • At study entry, weeks 2 and 4, every 4 weeks up to week 96 and every 6 weeks thereafter for Group 1 participants and at study entry, weeks 2 and 4, every 4 weeks up to week 144 and every 12 weeks thereafter for Group 2 and 3 participants The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events .Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RCC website at (http://rcc.tech-res.com/).
Investigations Liver function test increased	0.00% 0/6 • At study entry, weeks 2 and 4, every 4 weeks up to week 96 and every 6 weeks thereafter for Group 1 participants and at study entry, weeks 2 and 4, every 4 weeks up to week 144 and every 12 weeks thereafter for Group 2 and 3 participants The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events .Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RCC website at (http://rcc.tech-res.com/).	4.8% 1/21 • At study entry, weeks 2 and 4, every 4 weeks up to week 96 and every 6 weeks thereafter for Group 1 participants and at study entry, weeks 2 and 4, every 4 weeks up to week 144 and every 12 weeks thereafter for Group 2 and 3 participants The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events .Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RCC website at (http://rcc.tech-res.com/).	0.00% 0/16 • At study entry, weeks 2 and 4, every 4 weeks up to week 96 and every 6 weeks thereafter for Group 1 participants and at study entry, weeks 2 and 4, every 4 weeks up to week 144 and every 12 weeks thereafter for Group 2 and 3 participants The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events .Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RCC website at (http://rcc.tech-res.com/).
Investigations Neutrophil count decreased	0.00% 0/6 • At study entry, weeks 2 and 4, every 4 weeks up to week 96 and every 6 weeks thereafter for Group 1 participants and at study entry, weeks 2 and 4, every 4 weeks up to week 144 and every 12 weeks thereafter for Group 2 and 3 participants The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events .Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RCC website at (http://rcc.tech-res.com/).	4.8% 1/21 • At study entry, weeks 2 and 4, every 4 weeks up to week 96 and every 6 weeks thereafter for Group 1 participants and at study entry, weeks 2 and 4, every 4 weeks up to week 144 and every 12 weeks thereafter for Group 2 and 3 participants The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events .Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RCC website at (http://rcc.tech-res.com/).	0.00% 0/16 • At study entry, weeks 2 and 4, every 4 weeks up to week 96 and every 6 weeks thereafter for Group 1 participants and at study entry, weeks 2 and 4, every 4 weeks up to week 144 and every 12 weeks thereafter for Group 2 and 3 participants The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events .Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RCC website at (http://rcc.tech-res.com/).
Nervous system disorders Dizziness	0.00% 0/6 • At study entry, weeks 2 and 4, every 4 weeks up to week 96 and every 6 weeks thereafter for Group 1 participants and at study entry, weeks 2 and 4, every 4 weeks up to week 144 and every 12 weeks thereafter for Group 2 and 3 participants The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events .Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RCC website at (http://rcc.tech-res.com/).	0.00% 0/21 • At study entry, weeks 2 and 4, every 4 weeks up to week 96 and every 6 weeks thereafter for Group 1 participants and at study entry, weeks 2 and 4, every 4 weeks up to week 144 and every 12 weeks thereafter for Group 2 and 3 participants The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events .Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RCC website at (http://rcc.tech-res.com/).	6.2% 1/16 • At study entry, weeks 2 and 4, every 4 weeks up to week 96 and every 6 weeks thereafter for Group 1 participants and at study entry, weeks 2 and 4, every 4 weeks up to week 144 and every 12 weeks thereafter for Group 2 and 3 participants The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events .Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RCC website at (http://rcc.tech-res.com/).
Psychiatric disorders Psychotic disorder	0.00% 0/6 • At study entry, weeks 2 and 4, every 4 weeks up to week 96 and every 6 weeks thereafter for Group 1 participants and at study entry, weeks 2 and 4, every 4 weeks up to week 144 and every 12 weeks thereafter for Group 2 and 3 participants The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events .Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RCC website at (http://rcc.tech-res.com/).	4.8% 1/21 • At study entry, weeks 2 and 4, every 4 weeks up to week 96 and every 6 weeks thereafter for Group 1 participants and at study entry, weeks 2 and 4, every 4 weeks up to week 144 and every 12 weeks thereafter for Group 2 and 3 participants The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events .Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RCC website at (http://rcc.tech-res.com/).	0.00% 0/16 • At study entry, weeks 2 and 4, every 4 weeks up to week 96 and every 6 weeks thereafter for Group 1 participants and at study entry, weeks 2 and 4, every 4 weeks up to week 144 and every 12 weeks thereafter for Group 2 and 3 participants The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events .Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RCC website at (http://rcc.tech-res.com/).
Skin and subcutaneous tissue disorders Rash	0.00% 0/6 • At study entry, weeks 2 and 4, every 4 weeks up to week 96 and every 6 weeks thereafter for Group 1 participants and at study entry, weeks 2 and 4, every 4 weeks up to week 144 and every 12 weeks thereafter for Group 2 and 3 participants The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events .Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RCC website at (http://rcc.tech-res.com/).	0.00% 0/21 • At study entry, weeks 2 and 4, every 4 weeks up to week 96 and every 6 weeks thereafter for Group 1 participants and at study entry, weeks 2 and 4, every 4 weeks up to week 144 and every 12 weeks thereafter for Group 2 and 3 participants The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events .Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RCC website at (http://rcc.tech-res.com/).	6.2% 1/16 • At study entry, weeks 2 and 4, every 4 weeks up to week 96 and every 6 weeks thereafter for Group 1 participants and at study entry, weeks 2 and 4, every 4 weeks up to week 144 and every 12 weeks thereafter for Group 2 and 3 participants The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events .Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RCC website at (http://rcc.tech-res.com/).

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

Restriction type: OTHER