Evaluation of Two Anti-HIV Treatment Strategies in Resource-Limited South African Communities

Summary

The purpose of this study is to determine the effectiveness of several anti-HIV treatment strategies in resource-poor South African communities. The strategies being studied are using specially trained doctors or nurses to administer HIV care.

Conditions

• HIV Infections

Interventions

BEHAVIORAL

Monitoring by an HIV-trained medical doctor

Participants will receive care from an HIV-trained medical doctor

BEHAVIORAL

Monitoring by an HIV-trained primary care nurse

Participants will receive care from an HIV-trained primary care nurse

DRUG

Efavirenz

600 mg tablet taken orally daily

DRUG

Lamivudine

150 mg tablet taken orally daily

DRUG

Lopinavir/Ritonavir

400 mg lopinavir/100mg ritonavir tablet taken orally twice daily

DRUG

Nevirapine

200 mg tablet taken orally for 14 days before taking a 200 mg tablet orally twice daily

DRUG

Stavudine

Tablet taken orally daily. Dosage depends on weight.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• CIPRA SA

  lead NETWORK

Principal Investigators

• James McIntyre, MBChB, MRCOG · Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital

• Ian Sanne, MBChB · University of the Witwatersrand, Thembaletu Clinic, Helen Joseph Hospital

• Robin Wood, MBChB, FCP (SA) · Department of Medicine, University of Cape Town

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-07-31

Primary Completion

2009-01-31

Completion

2009-01-31