Phase II open-label randomized multicenter trial to compare the efficacy and safety of two different doses of raltegravir and efavirenz, all in combination with tenofovir and lamivudine, in naive HIV-1-infected patients receiving rifampin for active tuberculosis. - REFLATE TB

• Conditions: HIV-1 Infection and tuberculosis; MedDRA version: 11.0Level: LLTClassification code 10020161Term: <Manually entered code. Term in E.1.1>

• Registration Number: EUCTR2008-004970-41-FR
• Lead Sponsor: Agence nationale de recherches sur le sida et les hépatites virales. ANRS.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-14
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Signed informed consent form, adult patients (at least 18 years old), plasma HIV RNA > 1000 copies/ml, HIV-1infection, ART naïve patients or ART for less than 3 months and more than 6 months ago, HIV resistance genotype at baseline showing no mutation to NNRTI and TDF or 3TC, for women of childbearing age negative urinary test for pregnancy and to accept contraceptive methods, confirmed or probable TB, TB treatment including rifampin started since 2 to 4 weeks before screening, to be affiliated to the National Health Care System.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

HIV-2 infection, 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, concomitant treatments including phenytoin or phenobarbital, prior TB with a Mycobacterium tuberculosis strain resistant to rifampin, TB treatment started for more than 4 weeks before screening.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified