MedTrace Logo

Antiretroviral Therapy for Advanced HIV Disease in South Africa

NCT00342355 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1771

Last updated 2013-05-21

Study results available
· View outcomes & findings →

Summary

This study will determine how well four different antiretroviral drug therapies work in patients with advanced HIV disease. The trial is part of the South Africa-U.S. Project Phidisa Programme - a collaboration between the South African Military Health Service (SAMHS) of the South African National Defense Force (SANDF), the U.S. Department of Defense, and the U.S. National Institutes of Health - to help prevent HIV transmission among South African military and civilian employees and their families.

Members of the SANDF with HIV infection may be eligible for this study. HIV-infected family members who are 14 years of age and older may also participate. All participants must have a CD4 count of less than 200 or an AIDS-defining illness.

Participants are randomly assigned to one of the following four antiretroviral drug regimens, which require taking 5 pills or more every day:

* AZT (zidovudine) + ddl (didanosine) + EFV (efavirenz)
* AZT (zidovudine) + ddl (didanosine) + r/LPV (lopinavir/ritonavir)
* D4T (stavudine) + 3TC (lamivudine) + EFV (efavirenz)
* D4T (stavudine) + 3TC (lamivudine) + r/LPV (lopinavir/ritonavir)

Patients are followed for up to 6 years. Clinic visits are scheduled once a month for the first 3 months and then once every 3 months for the next five years. Patients undergo a medical history, physical examination, and blood tests at each visit, and complete questionnaires of behavior, quality of life, and force readiness every year.

Conditions

Interventions

DRUG

Zidovudine

600 mg once daily

DRUG

Stavudine

40 mg once daily

DRUG

Didanosine

\<60 kg/125 mg twice daily or \>60kg/200 mg twice daily

DRUG

Lamivudine

300 mg once daily

DRUG

Efavirenz

600 mg once daily

DRUG

Lopinavir/Ritonavir

r/LPV 400mg/100mg twice daily

Sponsors & Collaborators

  • National Institutes of Health Clinical Center (CC)

    lead NIH

Principal Investigators

  • Michael Polis, MD · National Institute of Allergy and Infectious Diseases (NIAID)

  • Andrew Ratsela, MD · SAMHS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
Primary Completion
2008-03-31
Completion
2008-08-31

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Diseases

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 NCT00342355 on ClinicalTrials.gov