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Helping HIV Infected Patients in South Africa Adhere to Drug Regimens

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00076804
Recruitment Status : Terminated (DSMB stopped trial for futility)
First Posted : February 6, 2004
Results First Posted : July 2, 2010
Last Update Posted : March 27, 2015
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
HIV Infections Behavioral: Directly Observed Therapy Phase 2

Detailed Description:

South Africa has one of the worst and fastest growing HIV epidemics in the world. Highly active antiretroviral therapy (HAART) has been shown both at the individual and public health levels to reduce morbidity, mortality, and vertical and possibly horizontal HIV transmission. However, expenses, feasibility, long-term adherence, and effective delivery of HAART remain formidable barriers, particularly in developing nations. Recently, international initiatives have provided hope for widespread use of HAART at affordable cost in sub-Saharan Africa. Simplified, once-daily HAART regimens with directly observed therapy (DOT) may help to achieve high levels of treatment adherence, a key component for long-term viral suppression and treatment success. Peer advocates have been used to improve adherence with medical therapies in a variety of settings. This study will evaluate the effectiveness and feasibility of DOT using patient-nominated peer supervisors to improve adherence to HAART in HIV infected adults in South Africa.

Participants will be randomly assigned to either Peer-DOT-HAART or self-administration of a once-daily combination of the Western Cape Province ART program medications for 24 months. Study measures will include CD4 cell count and HIV viral load, adherence questionnaires, genotypic HAART resistance testing, and incidence of new or recurrent opportunistic infections.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 274 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: DOT-HAART for HIV-Infected South African Adults
Study Start Date : February 2005
Primary Completion Date : September 2008
Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Use of a patient nominated peer supporter who will observe the morning dose of ARVs
Behavioral: Directly Observed Therapy
Use of a patient nominated peer supporter who will observe the morning dose of ARVs
No Intervention: 2
Self administration of ARVs

Outcome Measures

Primary Outcome Measures :
  1. Impact of DOT Compared to Self-administered Treatment as Measured by HIV Viral Load at 12 Months of Treatment [ Time Frame: at 12 and 24 months of treatment ]
    Proportion of Patients with HIV RNA Levels of <400 at 12 Months - Intention-to-treat

  2. Impact of DOT Compared to Self-administered Treatment as Measured by HIV Viral Load at 24 Months of Treatment [ Time Frame: 24 months ]
    Proportion of Patients with HIV RNA Levels of <400 Copies/mL at 24 Months [Intention-to-treat (ITT)

  3. Immunological Response: Median CD4 (IQR) Cell Count Increase From Baseline at 12 Months by Study Arm [ Time Frame: 12 months ]
  4. Immunological Response: Median CD4 (IQR) Cell Count Increase From Baseline at 24 Months by Study Arm [ Time Frame: 24 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • HIV infected
  • Viral load greater than 1000 copies/ml
  • CD4 count of 200 cells/mm3 or less, or World Health Organization Stage 4 disease
  • Living in the area of the study site
  • Had a known address for more than 3 months
  • Willing to nominate a treatment supervisor (a close family member, sexual partner, friend, or community volunteer) to observe daily ingestion of tablets
  • Willing to disclose HIV status to a treatment supervisor and ready to commit to long-term antiretroviral therapy
  • Acceptable methods of contraception

Exclusion Criteria:

  • Pregnant
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00076804

South Africa
University of Cape Town
Cape Town, South Africa, 7925
Sponsors and Collaborators
Johns Hopkins University
University of Cape Town
Principal Investigator: Richard E Chaisson, MD Johns Hopkins University
More Information

Responsible Party: Dr. Richard Chaisson, Director, Center for TB Research, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00076804     History of Changes
Other Study ID Numbers: 1R01AI055359-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 6, 2004    Key Record Dates
Results First Posted: July 2, 2010
Last Update Posted: March 27, 2015
Last Verified: March 2015

Keywords provided by Dr. Richard Chaisson, Johns Hopkins University:
Directly Observed Therapy

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases