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

• Register: ClinicalTrials.gov
• Last refreshed on: 29 March 2021
• Main ID: NCT02104700
• Date of registration: 01/04/2014
• Prospective Registration: Yes
• Primary sponsor: Philip Grant
• Public title: Switch From Nevirapine-based Regimen to Once a Day Rilpivirine/Emtricitabine/Tenofovir Near-Rwanda
• Scientific title: Switch From Nevirapine-based Regimen to Once a Day Rilpivirine/Emtricitabine/Tenofovir in Virologically-suppressed HIV-infected Rwandans (Near-Rwanda)"
• Date of first enrolment: April 2014
• Target sample size: 150
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02104700
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2/Phase 3

Countries of recruitment

Rwanda

Contacts

• Name: Andrew Zolopa, MD
• Affiliation: Stanford University

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

HIV

Intervention(s)

Drug: Rilpivirine/Emtricitabine/Tenofovir

Primary Outcome(s)

Explore Efficacy [Time Frame: 24 weeks]

Secondary Outcome(s)

HIV RNA levels [Time Frame: 24 weeks]

Secondary ID(s)

ISR-In-US-264-0123

Near Rwanda

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Gilead Sciences