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Anti-HIV Drugs for Treating Infants Who Acquired HIV Infection at Birth

NCT00102960 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 377

Last updated 2021-11-02

Study results available
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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.

Conditions

  • HIV Infections

Interventions

DRUG

Abacavir sulfate

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.

DRUG

Didanosine

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.

DRUG

Efavirenz

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.

DRUG

Lamivudine

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

DRUG

Lopinavir/Ritonavir

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

DRUG

Nevirapine

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.

DRUG

Zidovudine

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

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • James McIntyre, MBChB, MRCOG · Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital, University of the Witwatersrand

  • Avy Violari, MBChB, FCPSA · Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital, University of the Witwatersrand

  • Mark F. Cotton, PhD · Department of Pediatrics and Child Health, Faculty of Health Sciences, University of Stellenbosch

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
12 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2012-09-30
Completion
2013-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00102960 on ClinicalTrials.gov