Status:
COMPLETED
Raltegravir Versus Efavirenz in Naive HIV-1-infected Patients Receiving Rifampin for Active Tuberculosis
Lead Sponsor:
ANRS, Emerging Infectious Diseases
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Ministry of Health, Brazil
Conditions:
HIV-1 Infection
Tuberculosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Phase III trial evaluating raltegravir as an alternative to efavirenz for antiretroviral treatment of HIV-infected patients with tuberculosis.
Detailed Description
Phase III multicenter, international, open-label, randomized trial evaluating non-inferiority of raltegravir at dose of 400mg BID compared to efavirenz 600mg QD, both in association with tenofovir dis...
Eligibility Criteria
Inclusion
- Signed informed consent form
- Aged 18 years or more
- Confirmed HIV-1 infection as documented at any time prior to trial entry per national HIV testing procedures
- ART naïve
- For women of childbearing potential i.e. women of childbearing age who are not menopausal, or permanently sterilized (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy) or not refraining from sexual activity: negative urinary test for pregnancy and acceptance to use contraceptive methods
- Confirmed or probable active TB disease of any location, except neurological (meningitis or encephalitis), according to the following criteria based on WHO updated definitions:
- Bacteriologically confirmed pulmonary TB (PTB) or extrapulmonary TB (EPTB), e.g. TB with a biological specimen positive by smear microscopy, culture or nucleic acid amplification test (such as Xpert MTB/RIF).
- Clinically diagnosed PTB or EPTB with typical histological evidence of TB (caseous or granulomatous) on biopsy specimen or positive urinary LAM test OR a significant improvement on TB treatment
- Ongoing standard rifampin-containing TB treatment for ≤8 weeks at inclusion
- For French patients, affiliation to a Social Security program
Exclusion
- HIV-2 co-infection
- Impaired hepatic function (icterus or ALT (SGPT) \> 5ULN)
- Hemoglobin \< 6.5 g/dl
- Creatinine clearance \<60ml/min (assessed by the Cockroft and Gault formula)
- Mycobacterium tuberculosis strain resistant to rifampin (current or past history).
- Neurological TB (meningitis or encephalitis)
- Severe associated diseases requiring specific treatment (including all specific AIDS defining illnesses other than TB, and any severe sepsis)
- Any condition which might, in the investigator's opinion, compromise the safety of treatment and/or patient's adherence to trial procedures including very severe TB-related clinical condition
- Concomitant treatments including phenytoin or phenobarbital (compounds interacting with UGT1A1)
- For HCV co-infected patients, need to start specific treatment for hepatitis during the trial duration
- For women of childbearing potential:
- Pregnancy or breastfeeding
- Refusal to use a contraceptive method
- Any history of ARV intake for prevention of mother to child transmission of HIV (pMTCT)
- Subjects participating in another clinical trial evaluating therapies and including an exclusion period that is still in force during the screening phase
- Person under guardianship, or deprived of freedom by a judicial or administrative decision
Key Trial Info
Start Date :
September 11 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 28 2018
Estimated Enrollment :
460 Patients enrolled
Trial Details
Trial ID
NCT02273765
Start Date
September 11 2015
End Date
November 28 2018
Last Update
December 31 2018
Active Locations (5)
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1
Laboratory of clinical research on STD/AIDS - IPEC/FIOCRUZ
Rio de Janeiro, Brazil
2
PACCI / CePReF Centre de Prise en charge de Recherche et de Formation
Abidjan, Côte d’Ivoire
3
Hôpital Saint Louis
Paris, France
4
Instituto Nacional de Saude / Hospital Geral de Machava
Maputo, Mozambique