Efficacy and Safety of 2 Raltegravir Doses in Naive HIV-1-infected Patients Receiving Rifampin for Active Tuberculosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2012-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Raltegravir is a potent antiretroviral agent that could be used as an alternative to efavirenz in HIV-1 infected patients with tuberculosis. However due to pharmacokinetic interactions, the optimal dose of raltegravir to be used in combination with rifampin is currently unknown.

This phase II open-label randomized multicenter trial is designed to estimate the antiviral efficacy of two doses of raltegravir and one dose of efavirenz at week 24, in HIV-1 naive patients co-infected with active tuberculosis (TB) treated with rifampin.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (0518-019)

NCT00293254

HIV Infections

COMPLETED PHASE3

A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (MK0518-018 EXT2)

NCT00293267

HIV Infections

COMPLETED PHASE3

Evaluation of the Safety and Efficacy of Reformulated Raltegravir (MK-0518) 1200 mg Once Daily in Combination With TRUVADA™ in Human Immunodeficiency Virus (HIV)-1 Infected, Treatment-Naive Participants (MK-0518-292)

NCT02131233

HIV Infection

COMPLETED PHASE3

A Study to Determine the Best Dose of Antivirals in Patients With Both TB and HIV

NCT00523458

HIV Infections Tuberculosis

TERMINATED PHASE4

Safety and Efficacy of Raltegravir+TDF+3TC in HBV/HIV Co-infected Patients

NCT01318096

HBV Coinfection HIV Infections

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infections Tuberculosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

efavirenz

Group Type ACTIVE_COMPARATOR

efavirenz

Intervention Type DRUG

tenofovir 245 mg / lamivudine 300 mg / efavirenz 600 mg

2

raltegravir 400 mg

Group Type EXPERIMENTAL

raltegravir

Intervention Type DRUG

tenofovir 245 mg / lamivudine 300 mg / raltegravir 400 mg

3

raltegravir 800 mg

Group Type EXPERIMENTAL

raltegravir

Intervention Type DRUG

tenofovir 245 mg / lamivudine 300 mg / raltegravir 800 mg

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

efavirenz

tenofovir 245 mg / lamivudine 300 mg / efavirenz 600 mg

Intervention Type DRUG

raltegravir

tenofovir 245 mg / lamivudine 300 mg / raltegravir 400 mg

Intervention Type DRUG

raltegravir

tenofovir 245 mg / lamivudine 300 mg / raltegravir 800 mg

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adult patients (at least 18 years old)
* Plasma HIV RNA \> 1000 copies/ml
* HIV-1-infection confirmed by ELISA and Western blot or Immunofluorescence
* ART naïve patients or
* ART for less than 3 months and more than 6 months ago ; an HIV resistance genotype at baseline showing no mutation to NNRTI and TDF or 3TC will be required
* For women of childbearing age, negative urinary test for pregnancy and to accept contraceptive methods: condom use and intra-uterine device when possible or declare no wish of pregnancy in the coming year.
* Confirmed or probable TB
* TB treatment including rifampin started since 2 to 8 weeks before randomisation
* Signed informed consent form
* For French patients, to be affiliated to the National Health Care System

Exclusion Criteria

* HIV-2 infection (single or with HIV-1)
* Woman who is pregnant or likely to become so, is breastfeeding or refuses to use contraception
* ALT\>2.5N, Hb \<7g/dl, neutrophils \< 750/mm3, platelet\<50 000/mm3, bilirubin \>5N, lipase \>3N
* Creatinine clearance \<60ml/min as assessed by the Cockcroft method
* Ongoing psychiatric pathology or any condition (including, but not limited to, the consumption of alcohol or drugs) which might, in the investigator's opinion, compromise the safety of treatment and/or patient compliance with the protocol
* Concomitant treatments including phenytoin or phenobarbital (compounds interacting with UGT1A1)
* Prior TB with a Mycobacterium tuberculosis strain resistant to rifampin
* TB treatment started for more than 8 weeks before randomisation

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No