The Mochudi Prevention Project ART Protocol

• Status: Terminated
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Harvard School of Public Health; Harvard School of Public Health (HSPH)
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Anti-Retroviral Agents; Efavirenz; Emtricitabine; Lamivudine; Lopinavir; Ritonavir; Tenofovir; Zidovudine

Criteria

Inclusion Criteria:

• HIV-1 infection

• CD4 cell count ≥ 250 cells/mm3

• HIV-1 RNA ≥ 50,000 cp/mL

• No AIDS-defining illness or other illness that would cause volunteer to be eligible for ART through the Botswana National Program (these volunteers should be referred to the National Program for treatment)

• Age 16 to 64 years

• Botswana citizen

• Resident of the north-east segment of Mochudi

• The following laboratory values obtained within 60 days prior to study enrollment:

• Absolute neutrophil count (ANC) ≥ 500 cells/mm3.

• Hemoglobin ≥ 7.0 g/dL.

• AST (SGOT), ALT (SGPT), and bilirubin ≤ 5 X ULN. Note: if the estimated creatinine clearance (by Cockgroft-Gault equation) is <60 mL/min, then TDF/FTC will be substituted with ZDV/3TC

• Ability to swallow oral medications.

• Ability and willingness of participant to give informed consent (or in case of participants < 18 years of age, ability and willingness to provide assent; and for parent/guardian to provide consent).

• Not currently involuntarily incarcerated.

• Karnofsky performance score ≥ 70 at time of study enrollment.

• If participating in sexual activity that could lead to pregnancy and of reproductive potential, female participants must use two reliable methods of contraception simultaneously, one of which must be a barrier method, while receiving protocol-specified medications, and for 12 weeks after stopping the medications.

• For participants < 18 years of age: Weight of 40kg or more

Exclusion Criteria:

• Receipt at any time prior to study enrollment of > 7 days cumulative treatment with any ARV or combination of ARVs (except ARVs taken for any length of time during pregnancy for the prevention of mother-to-child transmission (pMTCT) or ARVs taken for occupational exposure).

• Current receipt of 3-drug ART for pMTCT

• Allergy/sensitivity to any study drug or its formulations.

• Acute therapy for serious medical illnesses, in the opinion of the site investigator, within 14 days prior to enrollment.