DSMB stopped trial for futility

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.

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

Adverse Event data was collected throughout the duration of the study. It was assessed at each clinic visit and if the subject presented between visits.

Intervention was stopped at 12 months, transition phase did not ensure that participants developed a set of adherence strategies to replace DOT-ART. Low incidence of AIDS-defining illness and death limit our ability to make final conclusions