HIV/AIDS
Conditions
Interventions
Antiretroviral drugs administered with a moderate fat meal
Antiretroviral drugs administered with a high fat meal
Antiretroviral drugs administered without food
Sponsors
Infectious Diseases Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. HIV-infected male and non pregnant female adults > 18 and < 65 years of age 2. On ART containing lopinavir/ritonavir (LPV/r) plus 2NRTI with undetectable viremia (most recent HIV-RNA performed over preceding 12 months measuring <400 copies/ml) 3. No use of herbal/traditional medications or other medication known to induce or inhibit cytochrome P450 in previous 2 weeks 4. Ability to provide full written informed consent
Exclusion criteria
Exclusion criteria: 1. Anaemia ( Hemoglobin) 5 times upper limit of normal 3. Evidence of renal impairment ( serum creatinine > 300 ) 4. Severe bacterial or viral infection (requiring hospitalization or parenteral antibiotics within 2 weeks of screening) 5. Vomiting or diarrhoea lasting greater than 2 weeks within one month of screening 6. Refusal to adhere to prescribed meal conditions during administration of LPV/r plus 2 NRTIs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentrations of antiretroviral drugs when administered under different meal conditions | — |
Countries
Uganda
Contacts
Public ContactMargaret Denty
Regulatory Affairs Officer
Outcome results
None listed