CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 377 enrolled
Drug / intervention
Abacavir sulfate +6 moredrug
Likely dose
First-line: Zidovudine 240 mg/m² orally twice daily, Lamivudine 4 mg/kg orally twice daily, Lopinavir/Ritonavir orally twice daily (dose by age/weight); Second-line alternatives per protocol switching guidelinesAI-extracted
Key inclusion· 3
  • ✓HIV-infected infants
  • ✓Antiretroviral naive, or previously received only drugs for mother-to-child transmission prevention
  • ✓Parent or legal guardian willing to provide informed consent and comply with study requirements
Key exclusion· 7
  • ✕Major life-threatening congenital abnormalities
  • ✕Severe CDC Stage B or C disease
  • ✕Liver enzyme, absolute neutrophil count, hemoglobin, electrolyte, creatinine, or clinical toxicity Grade 3 or higher at screening
  • ✕Acute or clinically significant medical event precluding participation (though randomization permitted after resolution if age ≤12 weeks)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00102960
NCT00102960Phase 3Completed
CompareCT.gov

A Phase III, Randomized, Open-Label Trial to Evaluate Strategies for Providing Antiretroviral Therapy to Infants Shortly After Primary Infection in a Resource Poor Setting

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Feb 7, 2005·Updated Nov 2, 2021

In Brief

A Phase 3 clinical trial evaluating Abacavir sulfate, Didanosine, and 5 other interventions for HIV Infections. Completed, enrolled 377 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 7, 2005
Enrollment StartJul 1, 2005
Primary CompletionSep 1, 2012
Study CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 7.2 yearsPosted 21.4 years ago

Interventions

Abacavir sulfatedrug

Second Line Regimen: 8 mg/kg taken orally twice daily. Guidelines for switching from first line to second line therapy are available in the protocol.

Didanosinedrug

Second Line Regimen: Either 100 mg/m\^2 or 120 mg/m\^2 taken orally twice daily. Dosage depends on age. Guidelines for switching from first line to second line therapy are available in the protocol.

Efavirenzdrug

Second Line Regimen: taken orally once daily. Dosage depends on weight. Guidelines for switching from first line to second line therapy are available in the protocol.

Lamivudinedrug

First Line Regimen: 4 mg/kg taken orally twice daily

Lopinavir/Ritonavirdrug

First Line Regimen: taken orally twice daily. Dosage depends on age and weight.

Nevirapinedrug

Second Line Regimen: 150 - 200 mg/m\^2 taken orally twice daily. Guidelines for switching from first line to second line therapy are available in the protocol.

Zidovudinedrug

First Line Regimen: 240 mg/m\^2 taken orally twice daily