The Mochudi Prevention Project ART Protocol - Full Text View

Purpose

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


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS HIV/AIDS Medicines

Drug Information available for: Zidovudine Lamivudine Emtricitabine Tenofovir Efavirenz Ritonavir Lopinavir Tenofovir Disoproxil Fumarate

U.S. FDA Resources

Further study details as provided by Harvard School of Public Health:

Primary Outcome Measures:

The proportion of individuals with CD4≥250 cells/mm3 and VL≥50,000 cp/mL who start 3-drug ART [ Designated as safety issue: No ]
The proportion of patients experiencing Grade 3 or 4 clinical or laboratory adverse events by the end of follow-up [ Designated as safety issue: Yes ]
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 [ Designated as safety issue: No ]

Secondary Outcome Measures:

Presence of ARV drug resistance at time of virologic failure on first- and second-line treatment, among participants experiencing virologic failure [ Designated as safety issue: Yes ]
Time to first opportunistic infections [ Designated as safety issue: Yes ]
Time to death [ Designated as safety issue: Yes ]
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. [ Designated as safety issue: No ]
Motivation for / barriers to acceptance of ART will be analyzed descriptively [ Designated as safety issue: No ]


Enrollment:	11
Study Start Date:	September 2012
Study Completion Date:	September 2013
Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Intervention Details:

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


Ages Eligible for Study:	16 Years to 64 Years (Child, Adult)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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


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
Study First Received:	April 11, 2012
Last Updated:	March 18, 2015
Health Authority:	United States: Federal Government United States: Institutional Review Board Botswana: Health Research and Development Committee Botswana: Ministry of Health

Keywords provided by 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 Tenofovir Lopinavir Ritonavir Lamivudine Emtricitabine Zidovudine	Efavirenz Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Anti-HIV Agents HIV Protease Inhibitors Protease Inhibitors Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Antimetabolites Cytochrome P-450 CYP2C9 Inhibitors

ClinicalTrials.gov processed this record on September 26, 2016