Antiviral Responses to NNRTI-Based vs. PI-Based ARV Therapy in HIV Infected Infants Who Have or Have Not Received Single Dose NVP for Prevention of Mother-to-Child Transmission of HIV

Summary

A single dose of nevirapine (SD NVP) given to an HIV infected pregnant woman followed by a single dose to her infant has been shown to be an effective way of reducing the risk of mother-to-child transmission (MTCT) of HIV. The purpose of this study was to compare the effectiveness of a non-nucleoside reverse transcriptase inhibitor (NNRTI)-based antiretroviral regimen versus a protease inhibitor (PI)-based regimen in HIV infected infants who had or had not been exposed to SD NVP for prevention of MTCT.

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Conditions

• HIV Infections

Interventions

DRUG

Lamivudine

4 mg/kg twice daily

DRUG

Lopinavir/ritonavir

16/4 mg/kg twice daily for participants 2 months of age to less than 6 months of age; 12/3 mg/kg twice daily for participants at least 6 months of age and weighing less than 15 kg; 10/2.5 mg/kg twice daily for participants at least 6 months of age and weighing between 15 kg and 40kg; 400/100 mg twice daily for participants weighing more than 40 kg

DRUG

Nevirapine

Initially: 4 mg/kg for 14 days, then 7 mg/kg twice daily. In protocol version 2.0, Letter of Amendment 1 (September 2007), NVP dose increased to conform with WHO guidelines to: 160 to 200 mg/m\^2/dose to max 200 mg once daily for 14 days, then 160 to 200 mg/m\^2/dose to max 200 mg twice daily

DRUG

Zidovudine

180 mg/m\^2 twice daily

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

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

  collaborator NIH

• International Maternal Pediatric Adolescent AIDS Clinical Trials Group

  lead NETWORK

Principal Investigators

• Paul Palumbo, MD · Division of Infectious Diseases and International Health, Dartmouth-Hitchcock Medical Center

• Avy Violari, MD · Perinatal HIV Research Unit, University of Witwatersrand

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

2 Months

Max Age

36 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-12-31

Primary Completion

2010-12-31

Completion

2016-12-31

Countries

• India
• Malawi
• South Africa
• Tanzania
• Uganda
• Zambia
• Zimbabwe

Study Locations