NCT01583439

The Mochudi Prevention Project ART Protocol

An Evaluation of the Uptake and Safety of, and Adherence to Antiretroviral Treatment Among Individuals With CD4 ≥ 250 Cells/mm3 and HIV Virus Load ≥ 50,000 cp/mL

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Harvard School of Public Health (HSPH) · Academic / Other
• Sex: All
• Age: 16 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The goal of the "Mochudi Prevention Project" is to reduce the number of new HIV infections in the village of Mochudi, Botswana by promoting a comprehensive package of interventions that have proven to be effective in preventing the spread of HIV. This antiretroviral treatment (ART) clinical study is nested within the Mochudi Prevention Project, and is being conducted in the north-east segment (NES) of the village of Mochudi. The ART intervention component of the Mochudi Project is designed to determine the uptake of, adherence to, and feasibility of 3-drug combination ART as a component of a package of transmission prevention strategies. The hypotheses are 1) that ART (with 3 antiretrovirals from two classes of drugs) among participants with CD4 ≥ 250 cells/mm3 and VL ≥ 50,000 cp/mL will be acceptable and safe and 2) Eighty percent of eligible participants will agree to start 3-drug ART.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	highly active antiretroviral therapy: Lopinavir/Ritonavir, Lamivudine, Zidovudine, Efavirenz, Tenofovir Disoproxil Fumarate, Emtricitabine	Atripla: one tablet administered orally once daily at bedtime, each tablet comprised of co-formulated: Efavirenz (EFV) 600mg, Emtricitabine (FTC) 200mg, Tenofovir disoproxil fumarate (TDF) 300mg(EFV/FTC/TDF). Note: the study will generally provide the fixed-dose combination Atripla, but it will also be permissible for the same drugs to be used at the same doses as individual components (or as Truvada, coformulated TDF/FTC). Other drug substitutions may be made per the protocol.

Timeline

• Start date: 2012-09-01
• Primary completion: 2013-02-01
• Completion: 2013-09-01
• First posted: 2012-04-24
• Last updated: 2015-03-19

Locations

1 site across 1 country: Botswana