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Helping HIV Infected Patients in South Africa Adhere to Drug Regimens

NCT00076804 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 274

Last updated 2015-03-27

Study results available
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Summary

Three or more anti-HIV drugs are taken in combination as part of a treatment regimen. These drug regimens must be closely followed in order to be successful. Having a support person watch a patient take his or her anti-HIV drugs each day may help a patient follow his or her regimen. This study will see if patient-chosen treatment supporters help patients take HIV medicines correctly and improve their health.

Study hypothesis: The mean change in CD4 count at 12 and 24 months will be significantly higher in the directly observed therapy-highly active antiretroviral therapy (DOT-HAART) arm as compared to the self-administered arm.

Conditions

  • HIV Infections

Interventions

BEHAVIORAL

Directly Observed Therapy

Use of a patient nominated peer supporter who will observe the morning dose of ARVs

Sponsors & Collaborators

Principal Investigators

  • Richard E Chaisson, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Companies

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 NCT00076804 on ClinicalTrials.gov