A Phase 3 interventional study of Tenofovir + lamivudine + raltegravir and Tenofovir + lamivudine + efavirenz in HIV-1 Infection and Tuberculosis, sponsored by ANRS, Emerging Infectious Diseases. Completed at 5 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-31.
Sponsored by ANRS, Emerging Infectious Diseases · Phase 3, Interventional, and Treatment
Phase III trial evaluating raltegravir as an alternative to efavirenz for antiretroviral treatment of HIV-infected patients with tuberculosis.
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 disoproxil fumarate and lamivudine in ART-naïve HIV-1 infected patients with active TB disease receiving a rifampin-based TB treatment initiated \<8 weeks before inclusion. Patients will be randomized between 2 arms: the raltegravir (RAL) 400 mg bid arm or the efavirenz (EFV) 600 mg qd arm, each in combination with tenofovir disoproxil fumarate (TDF) and lamivudine (3TC) and will be followed for 48 weeks after entry in the trial (ART initiation).
1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.
This study's enrollment of 460 is above the median of 150 across 952 interventional studies indexed under Tuberculosis.
Browse Tuberculosis studies →ANRS, Emerging Infectious Diseases is the lead sponsor of 212 studies on the registry; 40 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Confirmed or probable active TB disease of any location, except neurological (meningitis or encephalitis), according to the following criteria based on WHO updated definitions:
Exclusion Criteria:
For women of childbearing potential:
Tenofovir 300mg QD + lamivudine 300mg QD + raltegravir 400mg BID
Drug: Tenofovir + lamivudine + raltegravir
Tenofovir 300mg QD + lamivudine 300mg QD + efavirenz 600mg QD
Drug: Tenofovir + lamivudine + efavirenz
In this arm, patients will receive the following medications : * Tenofovir disoproxil fumarate (TDF) 300 mg / Lamivudine (3TC) 300 mg FDC once a day (1 tablet qd) * Raltegravir (RAL) 400 mg (Isentress®): twice daily (1 tablet bid), with food In countries where TDF/3TC FDC is not available, the following separate drugs will be used: * Tenofovir disoproxil fumarate (TDF) 300 mg (Viread® 245 mg): once a day (1 tablet qd) * Lamivudine (3TC) : 300 mg once a day (300 mg, 1 tablet qd or 150 mg 2 tablets qd) * Raltegravir (RAL) 400 mg (Insentress®): twice daily (1 tablet bid), with food
In this arm, patients will receive the following medications, in accordance with treatment guidelines in all countries: * Tenofovir disoproxil fumarate (TDF) 300 mg / lamivudine (3TC) 300 mg FDC once a day (1 tablet qd) * Efavirenz (EFV) 600 mg: once a day, at night (1 tablet qd) OR: • Tenofovir disoproxil fumarate (TDF) 245 300 mg / lamivudine (3TC) 300 mg / efavirenz (EFV) 600 mg: once a day (1 tablet qd), at night, if possible without food In countries where TDF/3TC FDC is not available, the following separate drugs will be used: * Tenofovir disoproxil fumarate (TDF) 300 mg (Viread® 245 mg): once a day (1 tablet qd) * Lamivudine (3TC): 300 mg once a day (300 mg, 1 tablet qd or 150 mg 2 tablets qd) * Efavirenz (EFV) 600 mg: once a day, at night (1 tablet qd), if possible without food. The dose will not be adapted to the patient's body weight.
Proportion of patients in virologic success
Virologic success, defined as plasma HIV-1 RNA \<50 copies/mL, at week 48 with a window period of 42 to 54 weeks (snapshot algorithm). Discontinuation of the strategy (ie. permanent discontinuation of EFV, RAL), missing values, loss to follow-up and death will be considered as failure.
Time frame: Week 48
Time to death
Time frame: Week 48
Frequency, type and time to new or recurrent AIDS-defining illnesses
Time frame: Week 48
Frequency, type and time to severe HIV-associated non-AIDS defining illnesses
Time frame: Week 48
Frequency, type and time to grade 3 or 4 adverse events
Time frame: Week 48
Frequency, type and time to drug-induced clinical or biological adverse reactions of grade 3 or 4 or leading to treatment interruption
Time frame: Week 48
Change in plasma HIV-1 RNA from baseline to week 48
Time frame: Week 48
Proportion of patients in virologic success at each time point (HIV-1 RNA<50 copies/mL)
Time frame: Week 48
Time to virologic failure during follow-up
Time frame: Week 48
Frequency and time to new antiretroviral genotypic resistance in plasma RNA in patients with virologic failure
Time frame: Week 48
Change in CD4 cell counts from baseline to week 48
Time frame: Week 48
Frequency, type and time to Immune Reconstitution Inflammatory Syndrome
Time frame: Week 48
Frequency of tuberculosis treatment outcomes
Time frame: Week 48
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
ANRS, Emerging Infectious Diseases