Raltegravir Versus Efavirenz in Naive HIV-1-infected Patients Receiving Rifampin for Active Tuberculosis

• Status: Completed
• Trial end date: 2018-11-28
• Target enrollment: 0
• Participant gender: All

Summary

Phase III trial evaluating raltegravir as an alternative to efavirenz for antiretroviral treatment of HIV-infected patients with tuberculosis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ANRS, Emerging Infectious Diseases; French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Collaborators: Merck Sharp & Dohme Corp.; Ministry of Health, Brazil
• Treatments: Efavirenz; Lamivudine; Raltegravir Potassium; Rifampin; Tenofovir

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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