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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

February 3, 2004
March 10, 2014
February 2005
September 2008   (final data collection date for primary outcome measure)
  • 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 ]
Impact of DOT compared to self-administered treatment as measured by HIV viral load and CD4 lymphocyte counts at 12 and 24 months of treatment
Complete list of historical versions of study NCT00076804 on ClinicalTrials.gov Archive Site
Not Provided
Impact of DOT on HAART adherence, incidence of new and recurrent opportunistic infections, and proportion of genotypic resistance to antiretroviral agents
Not Provided
Not Provided
 
Helping HIV Infected Patients in South Africa Adhere to Drug Regimens
DOT-HAART for HIV-Infected South African Adults

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
Behavioral: Directly Observed Therapy
Use of a patient nominated peer supporter who will observe the morning dose of ARVs
  • Experimental: 1
    Use of a patient nominated peer supporter who will observe the morning dose of ARVs
    Intervention: Behavioral: Directly Observed Therapy
  • No Intervention: 2
    Self administration of ARVs
Nachega JB, Chaisson RE, Goliath R, Efron A, Chaudhary MA, Ram M, Morroni C, Schoeman H, Knowlton AR, Maartens G. Randomized controlled trial of trained patient-nominated treatment supporters providing partial directly observed antiretroviral therapy. AIDS. 2010 Jun 1;24(9):1273-80. doi: 10.1097/QAD.0b013e328339e20e.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
274
September 2008
September 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
South Africa
 
NCT00076804
1R01AI055359-01A1, 1 R01 AI055359-01A1
Yes
Dr. Richard Chaisson, Johns Hopkins University
Johns Hopkins University
University of Cape Town
Principal Investigator: Richard E Chaisson, MD Johns Hopkins University
Johns Hopkins University
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP