Helping HIV Infected Patients in South Africa Adhere to Drug Regimens - Full Text View

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator:	University of London
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00076804

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	DOT-HAART for HIV-Infected South African Adults

Resource links provided by NLM:

MedlinePlus related topics: AIDS AIDS Medicines

U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:

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 [ Time Frame: at 12 and 24 months of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Impact of DOT on HAART adherence, incidence of new and recurrent opportunistic infections, and proportion of genotypic resistance to antiretroviral agents [ Time Frame: 12, 18, 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
1: Experimental Use of a patient nominated peer supporter who sill observe the morning dose of ARVs	Behavioral: Directly Observed Therapy Use of a patient nominated peer supporter who sill observe the morning dose of ARVs
2: No Intervention Self administration of ARVs	Behavioral: Directly Observed Therapy Use of a patient nominated peer supporter who sill observe the morning dose 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 didanosine, lamivudine, and efavirenz 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

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

National Institute of Allergy and Infectious Diseases (NIAID)

University of London

Investigators

Principal Investigator:

Richard E Chaisson, MD

Johns Hopkins University

More Information

Additional Information:

Click here for more information on adherence This link exits the ClinicalTrials.gov site

Click here for more information on adhering to a regimen This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Johns Hopkins University ( Dr. Richard E. Chaisson )
Study ID Numbers:	1R01AI055359-01A1, 1 R01 AI055359-01A1
Study First Received:	February 3, 2004
Last Updated:	October 29, 2008
ClinicalTrials.gov Identifier:	NCT00076804 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Directly Observed Therapy
DOT

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on November 27, 2009