CompletedPhase 4

Raltegravir + Lamivudine/Abacavir in HIV/Tuberculosis Co-Infected Patients

Russia10 participantsStarted 2010-10

Plain-language summary

The study will investigate whether combination antiretroviral therapy of raltegravir and 3TC/ABC is effective and safe to use in tuberculosis (TB)/HIV co-infected adults receiving rifabutin-containing, first-line antituberculous treatment. Hypothesis:Combination antiretroviral therapy of raltegravir and 3TC/ABC and is effective and safe to use in tuberculosis (TB)/HIV co-infected adults receiving rifabutin-based first-line antituberculous treatment.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * ART-naïve HIV infected patients * Plasma HIV-1 RNA \>1,000 copies/mL at screening * CD4 cells 100-350 cells/mm3 * Have presumptive or confirmed diagnosis of Mycobacterium tuberculosis infection * Receiving first-line antituberculosis treatment * Documented negative results for the presence of HLA-B\*5701 allele Exclusion Criteria: * Pregnancy and Breastfeeding * Known allergy/sensitivity to study drugs or their formulations * A condition (including but not limited to active alcohol or drug use) that, in the opinion of the investigator, may interfere with patient adherence or safety

What they're measuring

Proportion of subjects with plasma HIV-1 RNA <50 copies/ml by the Time to Loss of Virologic Response (TLOVR) algorithm

Timeframe: 48 week

Trial details

NCT IDNCT01059422

SponsorCentral Institute of Epidemiology, Moscow, Russia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-03

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