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

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Philip Grant
• Collaborators: Gilead Sciences; Rwanda Biomedical Center
• Treatments: Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Nevirapine; Rilpivirine; Tenofovir

Criteria

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.