The Mochudi Prevention Project ART Protocol

NCT01583439 | Terminated DMC

• 2 other identifiers: BHP041R01AI083036
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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

Keywords

HIV Infections; Acquired Immunodeficiency Syndrome; Anti-HIV Agents; Sexually Transmitted Diseases, Viral; Immunologic Deficiency Syndromes; Immune System Diseases; Anti-Retroviral Agents; Antiviral Agents

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• 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

Interventions

highly active antiretroviral therapy: Lopinavir/Ritonavir, Lamivudine, Zidovudine, Efavirenz, Tenofovir Disoproxil Fumarate, Emtricitabine DRUG

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.

Eligibility Criteria

• Age: 16 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Harvard School of Public Health (HSPH): lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Deborah Retief Memorial Hospital

Mochudi, Botswana

Location

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; Sexually Transmitted Diseases, Viral; Immunologic Deficiency Syndromes; Immune System Diseases

Interventions

Ritonavir; Lamivudine; Zidovudine; efavirenz; Tenofovir; Emtricitabine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Slow Virus Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides; Thymidine; Organophosphonates; Organophosphorus Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Max Essex, DVM, PhD

  Harvard School of Public Health (HSPH)

  PRINCIPAL INVESTIGATOR

• Victor DeGruttola, S.M., Sc.D.

  Harvard School of Public Health (HSPH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator

Study Record Dates

• First Submitted: April 11, 2012
• First Posted: April 24, 2012
• Study Start: September 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: September 1, 2013
• Last Updated: March 19, 2015

Record last verified: 2015-03

Locations

BO (1)