The Mochudi Prevention Project ART Protocol

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01583439
• Other study ID #: BHP041
• Secondary ID: R01AI083036
• Status: Terminated
• Phase: N/A
• First received: April 11, 2012
• Last updated: March 18, 2015
• Start date: September 2012
• Est. completion date: September 2013

Study information

• Verified date: March 2015
• Source: Harvard School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review BoardBotswana: Health Research and Development CommitteeBotswana: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: September 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 64 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections

Intervention

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.

Locations

Country	Name	City	State
Botswana	Deborah Retief Memorial Hospital	Mochudi

Sponsors (2)

Lead Sponsor	Collaborator
Harvard School of Public Health	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

Botswana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of individuals with CD4=250 cells/mm3 and VL=50,000 cp/mL who start 3-drug ART			No
Primary	The proportion of patients experiencing Grade 3 or 4 clinical or laboratory adverse events by the end of follow-up			Yes
Primary	The proportion of participants with excellent adherence (defined as participant self-report of taking at least 95% of doses of antiretrovirals during the previous 4 days, on all assessments) by the end of follow-up			No
Secondary	Presence of ARV drug resistance at time of virologic failure on first- and second-line treatment, among participants experiencing virologic failure			Yes
Secondary	Time to first opportunistic infections			Yes
Secondary	Time to death			Yes
Secondary	Time to first episode of non-adherence: the first episode of non-adherence will be the report of the failure of a patient to take 95% of prescribed pills, or participant self-discontinuation of antiretrovirals.			No
Secondary	Motivation for / barriers to acceptance of ART will be analyzed descriptively			No