The Mochudi Prevention Project ART Protocol

Sponsor

Harvard School of Public Health (HSPH) (Other)

Overall Status

Terminated

CT.gov ID

NCT01583439

Collaborator

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Enrollment

Location

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: highly active antiretroviral therapy: Lopinavir/Ritonavir, Lamivudine, Zidovudine, Efavirenz, Tenofovir Disoproxil Fumarate, Emtricitabine	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

11 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Study Start Date :

Sep 1, 2012

Actual Primary Completion Date :

Feb 1, 2013

Actual Study Completion Date :

Sep 1, 2013

Outcome Measures

Primary Outcome Measures

The proportion of individuals with CD4≥250 cells/mm3 and VL≥50,000 cp/mL who start 3-drug ART []
The proportion of patients experiencing Grade 3 or 4 clinical or laboratory adverse events by the end of follow-up []
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 []

Secondary Outcome Measures

Presence of ARV drug resistance at time of virologic failure on first- and second-line treatment, among participants experiencing virologic failure []
Time to first opportunistic infections []
Time to death []
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. []
Motivation for / barriers to acceptance of ART will be analyzed descriptively []

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Deborah Retief Memorial Hospital	Mochudi		Botswana

Sponsors and Collaborators

Harvard School of Public Health (HSPH)
National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Principal Investigator: Max Essex, DVM, PhD, Harvard School of Public Health (HSPH)
Principal Investigator: Victor DeGruttola, S.M., Sc.D., Harvard School of Public Health (HSPH)