Clinical Drug Experience Knowledgebase

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.