HIV-1 Infection and tuberculosis MedDRA version: 11.0 Level: LLT Classification code 10020161 Term:
Conditions
Interventions
Trade Name: Sustiva
Product Name: Sustiva
Product Code: BMS-561525
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: EFAVIRENZ
CAS Number: 154598524
Concentration unit: mg milligram(s)
Conc
Sponsors
Agence nationale de recherches sur le sida et les hépatites virales. ANRS.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: To assess in each arm, each component of antiviral efficacy, separately To assess in each arm : - virologic success at the threshold of 50 copies/ml at week 48 and at the threshold of 400 copies/ml at week 24 and week 48, - evolution of HIV RNA and HIV DNA (total and 2LTR circular) from baseline to week 48 - emergence of genotypic resistance in patients with virologic failure, - evolution of CD4 cell counts from baseline to week 48, - progression to HIV disease progression or death, - treatment tolerance (grades 3 or 4), - success of TB treatment, - anti-TB resistance, - raltegravir and efavirenz through concentrations overtime. ;Primary end point(s): Virologic success at week 24, based on the TLOVR (time to loss of virologic response) algorithm, recommended by the FDA, with success defined as: - Plasma HIV RNA below 50 copies/ml at week 20, confirmed at week 24, - Absence of permanent discontinuation of either efavirenz, raltegravir or rifampin (before the end of anti-TB treatment) for any reason, - Absence of death, - Still follow-up at week 24. | — |
Countries
France
Outcome results
None listed