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

Tracking Information

First Received Date ^ICMJE

February 3, 2004

Last Updated Date

October 29, 2008

Start Date ^ICMJE

February 2005

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00076804 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Impact of DOT on HAART adherence, incidence of new and recurrent opportunistic infections, and proportion of genotypic resistance to antiretroviral agents

Descriptive Information

Brief Title ^ICMJE

Helping HIV Infected Patients in South Africa Adhere to Drug Regimens

Official Title ^ICMJE

DOT-HAART for HIV-Infected South African Adults

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.

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Behavioral: Directly Observed Therapy

Study Arms / Comparison Groups

Experimental: Use of a patient nominated peer supporter who sill observe the morning dose of ARVs
No Intervention: Self administration of ARVs

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

274

Completion Date

September 2008

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

South Africa

Administrative Information

NCT ID ^ICMJE

NCT00076804

Responsible Party

Dr. Richard E. Chaisson, Johns Hopkins University

Study ID Numbers ^ICMJE

1R01AI055359-01A1, 1 R01 AI055359-01A1

Study Sponsor ^ICMJE

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators ^ICMJE

University of London

Investigators ^ICMJE

Principal Investigator:

Richard E Chaisson, MD

Johns Hopkins University

Information Provided By

National Institute of Allergy and Infectious Diseases (NIAID)

Verification Date

December 2007

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