The Mochudi Prevention Project ART Protocol

• Register: ClinicalTrials.gov
• Last refreshed on: 30 March 2015
• Main ID: NCT01583439
• Date of registration: 11/04/2012
• Prospective Registration: Yes
• Primary sponsor: Harvard School of Public Health
• Public title: The Mochudi Prevention Project ART Protocol
• Scientific 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
• Date of first enrolment: September 2012
• Target sample size: 11
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT01583439
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
• Phase: N/A

Countries of recruitment

Botswana

Contacts

• Name: Max Essex, DVM, PhD
• Affiliation: Harvard School of Public Health

• Name: Victor DeGruttola, S.M., Sc.D.
• Affiliation: Harvard School of Public Health

Key inclusion & exclusion 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.



Age minimum: 16 Years
Age maximum: 64 Years
Gender: Both

Health Condition(s) or Problem(s) studied

HIV Infections

Intervention(s)

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

Primary Outcome(s)

The proportion of patients experiencing Grade 3 or 4 clinical or laboratory adverse events by the end of follow-up [Time Frame: 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 [Time Frame: No]

The proportion of individuals with CD4=250 cells/mm3 and VL=50,000 cp/mL who start 3-drug ART [Time Frame: No]

Secondary Outcome(s)

Time to first opportunistic infections [Time Frame: Yes]

Presence of ARV drug resistance at time of virologic failure on first- and second-line treatment, among participants experiencing virologic failure [Time Frame: 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. [Time Frame: No]

Motivation for / barriers to acceptance of ART will be analyzed descriptively [Time Frame: No]

Time to death [Time Frame: Yes]

Secondary ID(s)

BHP041

R01AI083036

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute of Allergy and Infectious Diseases (NIAID)