Back to results

The Mochudi Prevention Project ART Protocol

Primary Purpose

HIV Infections

Status

Terminated

Phase

Not Applicable

Locations

Botswana

Study Type

Interventional

Intervention

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

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV Infections, Acquired Immunodeficiency Syndrome, Anti-HIV Agents, Sexually Transmitted Diseases, Viral, Immunologic Deficiency Syndromes, Immune System Diseases, Anti-Retroviral Agents, Antiviral Agents

Eligibility Criteria

16 Years - 64 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

Deborah Retief Memorial Hospital

Outcomes

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

Full Information

NCT ID

NCT01583439

First Posted

April 11, 2012

Last Updated

March 18, 2015

Sponsor

Harvard School of Public Health (HSPH)

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

1. Study Identification

Unique Protocol Identification Number

NCT01583439

Brief Title

The Mochudi Prevention Project ART Protocol

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 Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Terminated

Why Stopped

Low Accrual.

Study Start Date

September 2012 (undefined)

Primary Completion Date

February 2013 (Actual)

Study Completion Date

September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Harvard School of Public Health (HSPH)

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

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

Intervention Description

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.

Primary Outcome Measure Information:

Title

The proportion of individuals with CD4≥250 cells/mm3 and VL≥50,000 cp/mL who start 3-drug ART

Title

The proportion of patients experiencing Grade 3 or 4 clinical or laboratory adverse events by the end of follow-up

Title

Secondary Outcome Measure Information:

Title

Presence of ARV drug resistance at time of virologic failure on first- and second-line treatment, among participants experiencing virologic failure

Title

Time to first opportunistic infections

Title

Time to death

Title

Motivation for / barriers to acceptance of ART will be analyzed descriptively

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Max Essex, DVM, PhD

Organizational Affiliation

Harvard School of Public Health (HSPH)

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

Harvard School of Public Health (HSPH)

Official's Role

Principal Investigator

Facility Information:

Facility Name

Deborah Retief Memorial Hospital

City

Mochudi

Country

Botswana

12. IPD Sharing Statement

Learn more about this trial

The Mochudi Prevention Project ART Protocol

We'll reach out to this number within 24 hrs