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Food-Atripla pharmacokinetic study

Evaluation of the pharmacokinetics of Atripla® with and without food in HIV-1 infected Ugandan adults

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR2009120001702102
Enrollment
Unknown
Registered
2009-11-26
Start date
2009-12-01
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV/AIDS

Interventions

Atripla administered with food
Atripla administered without food

Sponsors

Joint Clinical and Research Centre
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. HIV-1 infected male and non-pregnant female adults >18 years to < 65 years age 2. Stable on antiretroviral therapy containing TDF, FTC plus EFV for at least 1 month 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 written informed consent

Exclusion criteria

Exclusion criteria: 1. Anaemia (Hb 5 times upper limit of normal) 3. Evidence of renal impairment (serum creatinine > 300) 4. Severe viral or bacterial infection (requiring hospitalization or parenteral antibioticis within 2 weeks of screening). 5. Vomiting or diarrhea lasting greater than 2 weeks within one month of screening. 6. Refusal to adhere to prescribed meal conditions for TDF/FTC/EFV administration.

Design outcomes

Primary

MeasureTime frame
Plasma concentrations of antiretroviral agents administered with food or without food.—

Countries

Uganda

Contacts

Public ContactMohammed Lamorde

Study Coordinator

mlamorde@idi.co.ug+256-772185590

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026