HIV Clinical Trial
— Near-RwandaOfficial title:
Switch From Nevirapine-based Regimen to Once a Day Rilpivirine/Emtricitabine/Tenofovir in Virologically-suppressed HIV-infected Rwandans (Near-Rwanda)"
Verified date | March 2021 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study will be an open-label, pilot study in virologically suppressed patients comparing the efficacy, safety and tolerability of two Antiretroviral regimen strategies: Arm A: "Immediate switch" Rilpivirine/Emtricitabine/Tenofovir (single tablet formulation (STF))at randomization Arm B: "Delayed switch" Continue Nevirapine/Lamivudine/other Nucleoside reverse transcriptase inhibitor (NRTI)through 24 weeks then switch to STF of Rilpivirine/emtrictabine/tenofovir and followed through 48 weeks.
Status | Completed |
Enrollment | 150 |
Est. completion date | July 2016 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry. A second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test or a previous detectable HIV RNA level - HIV RNA level below the limit of quantification of the viral load assay in use in-country within the last 12 months - Screening HIV RNA level below the limit of quantification as defined by the local assay - At least twelve months of stable first-line antiretroviral therapy consisting of nevirapine and 2 nRTIs approved by the Rwandan HIV Treatment guidelines. (No prior changes in ART are allowed) - Enrolled in the Rwanda National ART Program with no in-country transfer within the program. - Negative TB symptom screen or eligible based on algorithm outlined in - Laboratory values obtained within 30 days prior to study entry: - Hemoglobin greater than 8.0 g/dL - Platelet count greater than 40,000/mm3 - AST (SGOT), ALT (SGPT), and alkaline phosphatase less than 5 X ULN - Total bilirubin less than 2.5 x ULN - Calculated creatinine clearance greater than 60 mL/min as estimated by the Cockcroft-Gault equation: - Ability to meet the nutritional requirements for rilpivirine; largest meal should consist of at least 400 total kcals and 117 kcals of fat (13 grams) to be assessed at screening. - For women of reproductive potential, negative serum or urine pregnancy test within 4 weeks of initiating study medications and a negative urine pregnancy test at the entry visit prior to randomization. - "Women of reproductive potential" is defined as women who have not been post-menopausal for at least 24 consecutive months (i.e., who have had menses within the preceding 24 months) and have not undergone surgical sterilization (e.g., hysterectomy, bilateral oophorectomy, or tubal ligation). - Age greater than18 years. - Ability and willingness of subject to give informed consent. Exclusion Criteria: - History of on-treatment virologic failure (defined as HIV RNA level greater than 200 copies/mL at or after 6 months of antiretroviral therapy) - Any change in prior ART. - Currently breastfeeding. - Active tuberculosis. - Serious illness requiring systemic treatment and/or hospitalization until candidate either completes therapy or is clinically stable on therapy, in the opinion of the site investigator, for at least 14 days prior to study entry. - NOTE: Isolated cutaneous Kaposi's Sarcoma, oral candidiasis, vaginal candidiasis, mucocutaneous herpes simplex, and other non-serious illnesses (as judged by the site investigator) have no restriction. - Known allergy/sensitivity to study drugs or their formulations. - Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. - Requirement for any current medications that are prohibited with any study treatment. |
Country | Name | City | State |
---|---|---|---|
Rwanda | Rwanda Military Hospital | Kinombe |
Lead Sponsor | Collaborator |
---|---|
Philip Grant | Gilead Sciences |
Rwanda,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Explore Efficacy | To compare proportion of subjects successfully maintaining a plasma viral load <200 copies /mL at week 24 in subjects randomized to rilpivirine/emtricitabine/tenofovir vs. in those randomized to initially continue nevirapine-based ART in this pilot study. | 24 weeks | |
Secondary | HIV RNA levels | To compare between arms the probability of having an HIV RNA level <50 and <400 copies/mL at 24 weeks | 24 weeks |
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