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Home > "H" Clinical Trials Conditions > Helping HIV Infected Patients in South Africa Adhere to Drug Regimens  Helping HIV Infected Patients in South Africa Adhere to Drug Regimens
Helping HIV Infected Patients in South Africa Adhere to Drug Regimens
For Condition: HIV Infections
Status: Not yet recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , University of Cape Town, Cape Town, South Africa,Aurum Health Research Unit, Welkom, South Africa,London School of Hygiene and Tropical Medicine, UK
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - HIV infected - Viral load > 1000 copies/ml - CD4 count =< 200 cells/mm3 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
Total Enrollment: 600
Location and Contact Information:
Aurum Health Research Unit
Meadowdale, , 1610
South Africa
Salome Charalambous +27-11-453-5066
University of Cape Town
Cape Town, , 7925
South Africa
Gary Maartens +27-21-406-6856
Additional Information:
Study ID Numbers: 1 R01 AI055359-01A1;
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00076804
Other Hiv Infections Studies:
1. Safety of and Immune System Response to an HIV Vaccine (EP HIV-1090) in HIV Uninfected Adults
2. Vaccine (ALVAC-HIV vCP1452) Use and Intermittent Withdrawal of Anti-HIV Drugs in Patients with HIV
3. The Safety and Effectiveness of a Two-Drug Combination in the Treatment of Patients with Hepatitis C Plus Advanced HIV Infections
4. Alternative Dosing Strategy for Anti-HIV Drugs
5. A Multicenter Placebo-Controlled Double Blind Study to Evaluate the Efficacy and Safety of Sandostatin ( SMS 201-995 ) in Patients with Acquired Immunodeficiency Related Diarrhea who were Either "Responders" or "Non-Responders" in a Prior Placebo-Controlled Double-Blind Sandostatin Study.
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Helping HIV Infected Patients in South Africa Adhere to Drug Regimens
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