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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Central Institute of Epidemiology, Moscow, Russia
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Abacavir; Dideoxynucleosides; Lamivudine; Raltegravir Potassium

Criteria

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