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The Mochudi Prevention Project ART Protocol

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ClinicalTrials.gov Identifier: NCT01583439
Recruitment Status : Terminated (Low Accrual.)
First Posted : April 24, 2012
Last Update Posted : March 19, 2015
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Max Essex, Harvard School of Public Health

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
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 : September 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Intervention Details:
    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.

Outcome Measures
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Primary Outcome Measures :
  1. The proportion of individuals with CD4≥250 cells/mm3 and VL≥50,000 cp/mL who start 3-drug ART
  2. The proportion of patients experiencing Grade 3 or 4 clinical or laboratory adverse events by the end of follow-up
  3. 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 :
  1. Presence of ARV drug resistance at time of virologic failure on first- and second-line treatment, among participants experiencing virologic failure
  2. Time to first opportunistic infections
  3. Time to death
  4. 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.
  5. Motivation for / barriers to acceptance of ART will be analyzed descriptively

Eligibility Criteria
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Ages Eligible for Study:   16 Years to 64 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01583439


Locations
Botswana
Deborah Retief Memorial Hospital
Mochudi, Botswana
Sponsors and Collaborators
Harvard School of Public Health
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Max Essex, DVM, PhD Harvard School of Public Health
Principal Investigator: Victor DeGruttola, S.M., Sc.D. Harvard School of Public Health
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Max Essex, Study Principal Investigator, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT01583439     History of Changes
Other Study ID Numbers: BHP041
R01AI083036 ( U.S. NIH Grant/Contract )
First Posted: April 24, 2012    Key Record Dates
Last Update Posted: March 19, 2015
Last Verified: March 2015

Keywords provided by Max Essex, Harvard School of Public Health:
HIV Infections
Acquired Immunodeficiency Syndrome
Anti-HIV Agents
Sexually Transmitted Diseases, Viral
 Immunologic Deficiency Syndromes
Immune System Diseases
Anti-Retroviral Agents
Antiviral Agents

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Ritonavir
Lopinavir
Tenofovir
Lamivudine
Emtricitabine
Zidovudine
 Efavirenz
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Antimetabolites
Cytochrome P-450 CYP2C9 Inhibitors