MedTrace Logo

Pharmacokinetics (PK) Study of Once Daily Darunavir/Ritonavir and Twice and Once Daily Raltegravir in HIV-infected Subjects

NCT01047995 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2010-01-13

No results posted yet for this study

Summary

The study aims to help us understand if the HIV drugs darunavir (taken with ritonavir) and raltegravir will affect each other when they are given at the same time.

The purpose of the study is to assess the pharmacokinetics (how a drug is absorbed, distributed and eliminated from your body) of darunavir and ritonavir when these are taken with and without raltegravir.

The duration of the study will be up to 50 days plus a screening visit which will take place up to 4 weeks prior to the start of the study, and a follow up visit which takes place 1-2 weeks after the last dose of study medication.

Subjects will continue to take 2 of their usual drugs (those called nucleoside reverse transcriptase inhibitors -NRTI) throughout the study.

For the first 21 days subjects will take their usual NRTI plus raltegravir 400mg twice daily. After this, subjects will also receive either:

Group 1) Darunavir/ritonavir 800mg/100mg once daily AND raltegravir 400mg twice daily or Group 2) Darunavir/ritonavir 800mg/100mg once daily AND raltegravir 800mg once daily

Subjects will take this regimen for 14 days. Subjects will be randomly allocated to either Group 1 or 2. You will have an equal (50/50) chance of being allocated to Group 1 or 2.

Conditions

  • HIV Infections

Interventions

DRUG

Raltegravir plus Darunavir/ritonavir

Phase 1, all subjects (n = 24): Raltegravir 400 mg twice daily for 21 days Phase 2 Group 1 (n = 12): Darunavir/ritonavir 800/100 mg once daily plus raltegravir 400 mg twice daily for 14 days Phase 3, all subjects (n = 24): Darunavir/ritonavir 800/100 mg once daily for 14 days.

DRUG

Raltegravir plus Darunavir/ritonavir

Phase 1, all subjects (n = 24): Raltegravir 400 mg twice daily for 21 days Phase 2 Group 2 (n = 12): Darunavir/ritonavir 800/100 mg once daily plus raltegravir 800 mg once daily for 14 days Phase 3, all subjects (n = 24): Darunavir/ritonavir 800/100 mg once daily for 14 days.

Sponsors & Collaborators

  • St Stephens Aids Trust

    lead OTHER

Principal Investigators

  • Marta Boffito, Dr · St Stephen's AIDS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United Kingdom

Study Locations

More Related Trials

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 NCT01047995 on ClinicalTrials.gov