Switch From Nevirapine-based Regimen to Once a Day Rilpivirine/Emtricitabine/Tenofovir

Not Recruiting

Trial ID: NCT02104700

Purpose

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.

Official Title

Switch From Nevirapine-based Regimen to Once a Day Rilpivirine/Emtricitabine/Tenofovir in Virologically-suppressed HIV-infected Rwandans (Near-Rwanda)"

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.

Intervention(s):

drug: Rilpivirine/Emtricitabine/Tenofovir

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305