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Pharmacokinetic Interactions Between Antiretroviral Agents and Antimalarial Drug Combinations

NCT00697892 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2013-06-06

No results posted yet for this study

Summary

The purpose of the study is to determine in healthy volunteers whether certain anti-HIV medications (lopinavir/ritonavir and efavirenz) affect the drug levels of certain anti-malarial medications (artesunate/ amodiaquine and artemether/ lumefantrine) and vice versa. Since these drugs are degraded using overlapping pathways in the liver, it is predicted that changes in both drug level and overall drug exposure will be observed.

Conditions

Interventions

DRUG

lopinavir/ritonavir

Two tablets of lopinavir 200mg / ritonavir 50mg orally twice daily with food for 26 days

DRUG

efavirenz

One 600mg tablet orally once daily before bedtime on an empty stomach for 26 days

DRUG

artemether/lumefantrine

4 tablets of artemether 20mg/lumefantrine 120mg twice daily with food. 2 three-day courses will be administered (with washout in between) during the duration of the trial.

Sponsors & Collaborators

  • Fran Aweeka

    lead OTHER

Principal Investigators

  • Francesca T Aweeka, PharmD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2008-12-31
Completion
2010-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00697892 on ClinicalTrials.gov