Clinical trial NCT02104700 (phase 2/phase 3, status: unknown status)
Conditions: hiv
ICD codes: B20, Z71.7, O98.72, Z21, O98.73, R75, Z11.4
Drugs: rilpivirine/emtricitabine/tenofovir
SMILES: [H][C@@](C)(CN1C=NC2=C(N)N=CN=C12)OCP(=O)(OCOC(=O)OC(C)C)OCOC(=O)OC(C)C
Eligibility 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.