Second-line antiretrovirals - Food interaction study

Not Applicable

• Conditions: HIV/AIDS

• Registration Number: PACTR2010030001953121
• Lead Sponsor: Infectious Diseases Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-03-02
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 15

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

1. Anaemia ( Hemoglobin) < 10 g/dl
2. Evidence of liver impairment ALT > 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Plasma concentrations of antiretroviral drugs when administered under different meal conditions