MedTrace Logo

Anti-HIV Treatment Interruptions in HIV Infected Adults in South Africa

NCT00100646 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2014-08-27

No results posted yet for this study

Summary

HIV infected people often must take anti-HIV drugs for long periods, leading to long-term drug exposure and toxicity. Interruptions in anti-HIV therapy, also known as structured treatment interruptions (STIs), may have few negative health effects and may be helpful to the overall long-term health of HIV-infected people. The purpose of this study is to determine if sequential short-term STIs of antiretroviral therapy (ART) in HIV infected individuals in a resource-constrained environment can retain the immune reconstitution benefits of continuous treatment while potentially lessening rates of toxicity associated with continuous therapy strategies and at the same time, lessen costs associated with ART.

Conditions

  • HIV Infections

Interventions

BEHAVIORAL

Structured treatment interruption

Interruptions in treatment will last 2, 4, and 8 weeks in between 16-week periods of ART

DRUG

Lamivudine

300 mg tablet taken orally daily

DRUG

Lopinavir/Ritonavir

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

DRUG

Stavudine

Dosage dependent on weight

BIOLOGICAL

Rabies de novo antigen

Vaccine injected intramuscularly

Sponsors & Collaborators

  • The Wistar Institute

    lead OTHER

Principal Investigators

  • Luis J. Montaner, DVM, MSc, DPhil · The Wistar Institute

  • Ian M. Sanne, MBBCH, FCP(SA), DTM&H · University of Witwatersrand, South Africa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • South Africa

Study Locations

More Related Trials

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 NCT00100646 on ClinicalTrials.gov