The Mochudi Prevention Project ART Protocol

NCT ID: NCT01583439

Last Updated: 2015-03-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2013-09-30

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Harvard School of Public Health (HSPH)

OTHER

Sponsor Role: lead

Responsible Party

Max Essex

Study Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Max Essex, DVM, PhD

Role: PRINCIPAL_INVESTIGATOR

Harvard School of Public Health (HSPH)

Victor DeGruttola, S.M., Sc.D.

Role: PRINCIPAL_INVESTIGATOR

Harvard School of Public Health (HSPH)

Locations

Deborah Retief Memorial Hospital

Mochudi, , Botswana

Countries

Botswana

Other Identifiers

R01AI083036

Identifier Type: NIH

Identifier Source: secondary_id

View Link

BHP041

Identifier Type: -

Identifier Source: org_study_id