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Completed

NCT Number: NCT00822315

Efficacy and Safety of 2 Raltegravir Doses 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.

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Key information

Conditions

HIV Infections Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Communicable Diseases Genital Diseases Gram-Positive Bacterial Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mycobacterium Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tuberculosis Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Genral de Nova Iguaçu, Nova Iguaçu, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Efavirenz

Drug

tenofovir 245 mg / lamivudine 300 mg / efavirenz 600 mg

raltegravir

Drug

tenofovir 245 mg / lamivudine 300 mg / raltegravir 400 mg

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. Evolution in HIV RNA and HIV DNA (total and 2 LTR circular) from baseline to week 48

    Time frame: 48 weeks

  4. 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

  5. Evolution of CD4 cell counts from baseline to week 48

    Time frame: 48 weeks

  6. Frequency, type and time to a new AIDS-defining event or death

    Time frame: Through out the trial

  7. Frequency, type, time to grade 3 or 4 adverse event

    Time frame: Through out the trial

  8. Rate of success of TB treatment

    Time frame: 48 weeks

  9. Anti-TB resistance rate

    Time frame: 48 weeks

  10. Evolution of raltegravir and efavirenz trough concentration

    Time frame: Through out the trial

Sponsors and collaborators

Lead sponsor

ANRS, Emerging Infectious Diseases

Other Gov

Collaborators

  • Gilead Sciences
  • Merck Sharp & Dohme LLC

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Jan 14, 2009
Registry last updated
Jul 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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