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
|
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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 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 |

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

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Ages Eligible for Study: | 16 Years to 64 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
Botswana | |
Deborah Retief Memorial Hospital | |
Mochudi, Botswana |
Principal Investigator: | Max Essex, DVM, PhD | Harvard School of Public Health | |
Principal Investigator: | Victor DeGruttola, S.M., Sc.D. | Harvard School of Public Health |
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 |