Rilpivirine Food PK Study
- Conditions
- HIV/AIDS
- Registration Number
- PACTR201301000480567
- Lead Sponsor
- Infectious Diseases Institute, Makerer University College of Health Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 15
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
1.HIV-1 RNA > 400 copies/mL at screening visit
2.Serum hemoglobin < 8g/dl
3.Elevations in serum levels of alanine transaminase (ALT), aspartate transaminase (AST) or creatinine above 3 times the upper limit of normal
4.Evidence of QT prolongation on electrocardiogram (ECG) QTc (Rate adjusted QT interval) >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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Steady-state plasma concentrations of rilpivirine
- Secondary Outcome Measures
Name Time Method Short-term safety and tolerability of Complera® in HIV-1 infected patients