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Efficacy and Safety of 2 Raltegravir Doses in Naive HIV-1-infected Patients Receiving Rifampin for Active Tuberculosis

This study has been completed.
Sponsor:
Collaborators:
Gilead Sciences
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier:
NCT00822315
First received: January 13, 2009
Last updated: July 16, 2013
Last verified: July 2013

January 13, 2009
July 16, 2013
July 2009
November 2011   (final data collection date for primary outcome measure)
Virologic success, using Time to Loss of Virologic Response (TLOVR) algorithm: -Plasma HIV RNA below 50 copies/ml at week 20, confirmed at week 24 -Absence of permanent treatment discontinuation -Absence of death -Still follow-up at week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00822315 on ClinicalTrials.gov Archive Site
  • Proportion of patients with virologic response with the following definitions: - Plasma HIV RNA <50 copies/ml at week 24 - Rate of strategy discontinuation and treatment changes - Proportion of death - Proportion of patients loss to follow-up [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients with virologic response with the following definitions: o Plasma HIV RNA <50 copies/ml o Plasma HIV RNA <400 copies/ml [ Time Frame: 24 and 48 weeks ] [ Designated as safety issue: No ]
  • Evolution in HIV RNA and HIV DNA (total and 2 LTR circular) from baseline to week 48 [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Rate of viral resistance mutations in the plasma at the time of virologic failure and in comparison with HIV-RNA mutations at W0 [ Time Frame: At the time of virologic failure ] [ Designated as safety issue: No ]
  • Evolution of CD4 cell counts from baseline to week 48 [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Frequency, type and time to a new AIDS-defining event or death [ Time Frame: Through out the trial ] [ Designated as safety issue: Yes ]
  • Frequency, type, time to grade 3 or 4 adverse event [ Time Frame: Through out the trial ] [ Designated as safety issue: Yes ]
  • Rate of success of TB treatment [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Anti-TB resistance rate [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Evolution of raltegravir and efavirenz trough concentration [ Time Frame: Through out the trial ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of 2 Raltegravir Doses in Naive HIV-1-infected Patients Receiving Rifampin for Active Tuberculosis
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

Raltegravir is a potent antiretroviral agent that could be used as an alternative to efavirenz in HIV-1 infected patients with tuberculosis. However due to pharmacokinetic interactions, the optimal dose of raltegravir to be used in combination with rifampin is currently unknown.

This phase II open-label randomized multicenter trial is designed 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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infections
  • Tuberculosis
  • Drug: efavirenz
    tenofovir 245 mg / lamivudine 300 mg / efavirenz 600 mg
  • Drug: raltegravir
    tenofovir 245 mg / lamivudine 300 mg / raltegravir 400 mg
  • Drug: raltegravir
    tenofovir 245 mg / lamivudine 300 mg / raltegravir 800 mg
  • Active Comparator: 1
    efavirenz
    Intervention: Drug: efavirenz
  • Experimental: 2
    raltegravir 400 mg
    Intervention: Drug: raltegravir
  • Experimental: 3
    raltegravir 800 mg
    Intervention: Drug: raltegravir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
155
May 2012
November 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients (at least 18 years old)
  • Plasma HIV RNA > 1000 copies/ml
  • HIV-1-infection confirmed by ELISA and Western blot or Immunofluorescence
  • ART naïve patients or
  • ART for less than 3 months and more than 6 months ago ; an HIV resistance genotype at baseline showing no mutation to NNRTI and TDF or 3TC will be required
  • For women of childbearing age, negative urinary test for pregnancy and to accept contraceptive methods: condom use and intra-uterine device when possible or declare no wish of pregnancy in the coming year.
  • Confirmed or probable TB
  • TB treatment including rifampin started since 2 to 8 weeks before randomisation
  • Signed informed consent form
  • For French patients, to be affiliated to the National Health Care System

Exclusion Criteria:

  • HIV-2 infection (single or with HIV-1)
  • 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
  • Ongoing psychiatric pathology or any condition (including, but not limited to, the consumption of alcohol or drugs) which might, in the investigator's opinion, compromise the safety of treatment and/or patient compliance with the protocol
  • Concomitant treatments including phenytoin or phenobarbital (compounds interacting with UGT1A1)
  • Prior TB with a Mycobacterium tuberculosis strain resistant to rifampin
  • TB treatment started for more than 8 weeks before randomisation
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil,   France
 
NCT00822315
ANRS 12180 REFLATE TB
Yes
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
  • Gilead Sciences
  • Merck Sharp & Dohme Corp.
Study Chair: Beatriz Grinsztejn, MD Fiocruz, Rio de Janiero, Brazil
Study Chair: Jean-Michel Molina, MD Hôpital Saint-Louis, Paris, France
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP