Helping HIV Infected Patients in South Africa Adhere to Drug Regimens

This study has been terminated.
(DSMB stopped trial for futility)
Sponsor:
Collaborator:
University of Cape Town
Information provided by (Responsible Party):
Dr. Richard Chaisson, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00076804
First received: February 3, 2004
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
HIV Infections
Behavioral: Directly Observed Therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: DOT-HAART for HIV-Infected South African Adults

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Proportion of Patients with HIV RNA Levels of <400 at 12 Months - Intention-to-treat

  • Impact of DOT Compared to Self-administered Treatment as Measured by HIV Viral Load at 24 Months of Treatment [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Proportion of Patients with HIV RNA Levels of <400 Copies/mL at 24 Months [Intention-to-treat (ITT)

  • Immunological Response: Median CD4 (IQR) Cell Count Increase From Baseline at 12 Months by Study Arm [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Immunological Response: Median CD4 (IQR) Cell Count Increase From Baseline at 24 Months by Study Arm [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 274
Study Start Date: February 2005
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00076804

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

Additional Information:
Publications:
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, 1 R01 AI055359-01A1
Study First Received: February 3, 2004
Results First Received: June 1, 2010
Last Updated: March 10, 2014
Health Authority: United States: Federal Government

Keywords provided by Johns Hopkins University:
Directly Observed Therapy
DOT

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

ClinicalTrials.gov processed this record on October 23, 2014