Phase 3
N=263
Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT00039741 ↗Enrolled (actual)
263
Serious AEs
18.3%
Results posted
Apr 2012
Primary outcome: Primary: Change in Viral Load Measured in log10 HIV-1 RNA Copies/ml — -3.16; -3.31; -3.26; -3.20 log10 HIV-1 RNA — p=0.26
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- NRTIs (ABC, FTC, FTC/TDF, 3TC, 3TC/AZT, d4T, TDF, ddC, AZT) (Drug); NNRTIs (EFV, NVP) (Drug); PIs (AMP, IDV, LPV/r, NFV, SQV, RTV) (Drug)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Viral Load Measured in log10 HIV-1 RNA Copies/ml |
-3.16; -3.31; -3.26; -3.20 | 0.26 |
| SECONDARY Rate of Grade 3 or Higher Signs, Symptoms, or Laboratory Abnormalities Experienced |
0.16; 0.17; 0.16; 0.17 | — |
| SECONDARY Participants With Significant HIV-related Clinical Events, Defined as CDC Category C (AIDS Defining) Diagnoses (Except for Recurrent Bacterial Infections)or Death |
6; 4; 5; 5 | — |
| SECONDARY Time to Switching to an Alternative Class ART Regimen (Based on Initial Randomized Regimen) |
NA; NA; NA; NA | — |
| SECONDARY Time to HIV-1 RNA of 400 Copies/ml or Greater During First-line Therapy or Permanent Discontinuation of First-line Therapy |
36; 68; 41; 72 | — |
| SECONDARY Time to HIV-1 RNA of 30,000 Copies/ml or Greater During Second-line Therapy or Permanent Discontinuation of Second-line Therapy |
126; 267; 267; 228 | — |
| SECONDARY Number of Children With an HIV-1 RNA Level Less Than 400 Copies/ml Regardless of Therapy at Week 204 |
92; 93; 95; 90 | — |
| SECONDARY Change in CD4% From Randomization to 4 Years |
13.7; 15.2; 15.1; 13.9 | — |
| SECONDARY Number of Children With HIV-1 RNA Less Than 400 Copies/ml and on Original Randomized Therapy at 24 Weeks |
92; 98; 99; 91 | — |
Summary
Little is known about what treatment combinations are best for HIV infected children. This study examined the long-term effectiveness of different anti-HIV drug combinations in children and strategies for switching treatment if the first treatment does not work. The study enrolled children who had not previously taken anti-HIV medication. Participants in this study were recruited in the United States, South America and Europe.
Some European children may also enroll in a substudy that will observe changes in body fat in children taking anti-HIV medications.
Eligibility Criteria
Inclusion Criteria
- Older than 30 days and younger than 18 years of age (may enroll up to the day before their 18th birthday)
- HIV infected
- Not previously on HAART or received anti-HIV drugs for less than 56 consecutive days after birth to prevent mother-to-infant HIV transmission. Participants who have previously received nevirapine for the prevention of mother-to-infant HIV transmission are not eligible for this study.
- Willing to use acceptable methods of contraception
Exclusion Criteria
- Grade 3 or 4 clinical or laboratory toxicity. More information on this criterion can be found in the protocol.
- Active opportunistic infection or a serious bacterial infection at the time of study entry
- Pancreas, nervous system, blood, liver, or kidney problems that make it impossible to take study medications
- Taking any medication that cannot be combined with the study medications in first-line therapy
- Received therapy for cancer
- Pregnant or breastfeeding
Data sourced from ClinicalTrials.gov (NCT00039741). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.