Completed PHASE2/PHASE3 INTERVENTIONAL 4-arm NCT00039741

Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children

A Phase II/III Randomized, Open-Label Study of Combination Antiretroviral Regimens and Treatment-Switching Strategies in HIV-1-Infected Antiretroviral Naive Children Between 30 Days and 18 Years of Age

Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Conditions HIV Infections

Interventions NNRTIs (EFV, NVP) NRTIs (ABC, FTC, FTC/TDF, 3TC, 3TC/AZT, d4T, TDF, ddC, AZT) PIs (AMP, IDV, LPV/r, NFV, SQV, RTV)

Updated 9 times since 2017 Last updated: Nov 3, 2021 Started: Aug 31, 2002 Primary completion: Aug 31, 2009 Completion: Mar 31, 2010

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2/PHASE3 trial investigates HIV Infections and is currently completed. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) leads this study, which shows 9 recorded versions since 2002 — indicating limited longitudinal coverage. Longitudinal tracking of infectious disease trials helps identify durability of treatment effects.

Status Flow

Change History

9 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE2/PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE2/PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE2/PHASE3

Phase: PHASE2_PHASE3 → PHASE2/PHASE3
Dec 2021 — Jul 2024 [monthly]

Completed PHASE2_PHASE3
Jan 2021 — Dec 2021 [monthly]

Completed PHASE2_PHASE3

▶ Show 4 earlier versions

Mar 2019 — Jan 2021 [monthly]

Completed PHASE2_PHASE3
Jun 2018 — Mar 2019 [monthly]

Completed PHASE2_PHASE3
Feb 2017 — Jun 2018 [monthly]

Completed PHASE2_PHASE3
Jan 2017 — Feb 2017 [monthly]

Completed PHASE2_PHASE3

First recorded

Aug 2002

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Allergy and Infectious Diseases (NIAID)
PENTA Foundation

Data source: National Institute of Allergy and Infectious Diseases (NIAID)

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Alhambra, United States , Chapel Hill, United States , Chicago, United States , Fort Lauderdale, United States , Gainesville, United States , Hartford, United States , Houston, United States , Long Beach, United States , Los Angeles, United States , Memphis, United States and 16 more locations