Status:
COMPLETED
Efficacy and Safety of 2 Raltegravir Doses in Naive HIV-1-infected Patients Receiving Rifampin for Active Tuberculosis
Lead Sponsor:
ANRS, Emerging Infectious Diseases
Collaborating Sponsors:
Gilead Sciences
Merck Sharp & Dohme LLC
Conditions:
HIV Infections
Tuberculosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 do...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT00822315
Start Date
July 1 2009
End Date
May 1 2012
Last Update
July 17 2013
Active Locations (9)
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1
Hospital Genral de Nova Iguaçu
Nova Iguaçu, Brazil
2
Hospital Nossa Senhora da Coceiçao
Porto Alegre, Brazil
3
Hospital Sanatorio Pertenon
Porto Alegre, Brazil
4
Ipec/Fiocruz
Rio de Janeiro, Brazil