Phase 3
Completed N=377
Anti-HIV Drugs for Treating Infants Who Acquired HIV Infection at Birth
Source: ClinicalTrials.gov NCT00102960 ↗Enrolled (actual)
377
Serious AEs
50.9%
Results posted
Nov 2018
Primary outcomePrimary: Time to Failure of First Line Therapy or Death — 48; 32; 26 Participants — p=0.02
Summary
The purpose of this study is to compare the effects of anti-HIV drug courses of different lengths in infants who became HIV infected at birth.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Failure of First Line Therapy or Death |
48; 32; 26 | 0.02 sig |
| PRIMARY Number of Participants Who Experienced Immunological Failure Defined as Failure of CD4% to Reach 20% or CD4% Falls Below 20% on Two Occasions, Within 4 Weeks, at Any Time After the First 24 Weeks of Therapy (Initial Therapy or Restart) |
9; 14; 11 | — |
| PRIMARY Number of Participants Who Experienced Regimen-limiting ART Drug Toxicity |
0; 0; 0 | — |
| PRIMARY Number of Participants Who Experienced Clinical Failure (Defined as Development of Severe CDC Stage B or Stage C Disease.) on Therapy. |
8; 6; 5 | — |
| PRIMARY Number of Participants Who Experienced Virological Failure Defined as Confirmed HIV-1 RNA Value of at Least 10,000 Copies Per/ml Recorded on Two Consecutive Separate Occasions After 24 Weeks of Treatment (Initial Therapy or Restart) |
10; 1; 1 | — |
| SECONDARY Number of Children Experiencing Severe CDC Stage B or Stage C Disease or Death (Cumulative After 3.5 Years) |
41; 28; 21 | 0.03 sig |
| SECONDARY Total Occurrence of Grade 3 or 4 Clinical Events |
170; 118; 88 | <0.0001 sig |
| SECONDARY Total Occurrence of Grade 3 or 4 Laboratory Events |
35; 44; 33 | 0.46 |
| SECONDARY Time From Randomization to Starting or Needing to Start Continuous Therapy |
20; 33; 70 | — |
| SECONDARY Number of Participants With Indicated Viral Resistance Mutations at the Time of Failure of First Line Therapy |
1; 1; 0; 1; 5; 1 | — |
| SECONDARY Time to Death Alone or Death Plus Life Threatening Stage C Events or HIV Events Associated With Permanent End-organ Damage. |
34; 18; 13 | 0.011 sig |
| SECONDARY Hospitalization Rates |
27.6; 16.4; 14.2 | — |
| SECONDARY Duration of Hospitalisation |
1018; 533; 414 | 0.004 sig |
| SECONDARY Time to First Hospitalization |
73.1; NA; NA | 0.0021 sig |
Eligibility Criteria
Inclusion Criteria for Infants:
NOTE: Per Letter of Amendment dated 04/04/07, Part B of this study is no longer recruiting participants. Per Letter of Amendment dated 09/16/08 Arm 1 of this study is longer recruiting.
- HIV infected
- Antiretroviral naive. Infants who have previously received antiretroviral drugs used to prevent mother-to-child transmission are eligible for the study.
- Parent or legal guardian willing to provide informed consent and comply with study requirements
Exclusion Criteria for Infants:
- Any major life-threatening congenital abnormalities
- Severe CDC Stage B or C disease
- Liver enzyme, absolute neutrophil count, hemoglobin, electrolyte, creatinine, or clinical toxicity of Grade 3 or higher at screening
- Any acute or clinically significant medical event that would preclude participation in the study. Randomization can take place as soon as the incurrent illness has resolved if the child is still less than or equal to 12 weeks of age.
- Use of investigational drugs
- Require certain medications. More information on this criterion can be found in the protocol.
- Inability to tolerate oral medication
- Birth weight less than 2 kg (4.4 lbs)
Data sourced from ClinicalTrials.gov (NCT00102960). 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. Informational only — not medical advice.