HIV/AIDS
Conditions
Interventions
Tablets Complera (200mg emtricitabine, 25 mg rilpivirine, 300mg TDF)
Sponsors
Infectious Diseases Institute, Makerer University College of Health Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study. 2. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 3. Aged between 18 to 65 years, inclusive. 4. Diagnosed with HIV-1 infection 5. Receiving first-line ART containing tenofovir disoproxil fumarate, efavirenz plus either emtricitabine or lamivudine for a minimum of 6 months
Exclusion criteria
Exclusion criteria: 1. HIV-1 RNA > 400 copies/mL at screening visit 2. Serum hemoglobin 450ms (men) or >470ms (women) 5. History of cardiac disease 6. Diarrhea lasting greater than one week 7. Use of known inhibitors or inducers of CYP3A4 . 8. Use of antacids, histamine-2 blockers or proton pump inhibitors 9. Use of herbal medications (information will be obtained from patients¿ medication history through interview with the patient) 10. Consumption of grapefruit within 1 week of first dose of study drug and for the duration of the study 11. Pregnant or lactating females 12. Participation in other clinical studies within four weeks before the current study begins and/or during study participation. Subjects should not be concurrently enrolled in another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Steady-state plasma concentrations of rilpivirine | — |
Secondary
| Measure | Time frame |
|---|---|
| Short-term safety and tolerability of Complera® in HIV-1 infected patients | — |
Countries
Uganda
Contacts
Public ContactMichael Enyakoit
Regulatory Officer / Infectious Diseases Institute
Outcome results
None listed