Raltegravir + Lamivudine/Abacavir in HIV/Tuberculosis Co-Infected Patients
Raltegravir + Lamivudine/Abacavir in HIV/Tuberculosis Co-Infected Patients
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.
This is a phase IIIB/IV, open-label, multi-center, single-arm descriptive pilot study of the
 efficacy and safety of RAL BID in combination with ABC/3TC QD in antiretroviral-naïve HIV-1
 infected individuals with a presumptive or confirmed diagnosis of tuberculosis, without
 planned comparative analyses.

 A goal of 40 subjects will be enrolled from 3 sites in the Russian Federation, including in
 our site, and receive RAL BID + 3TC/ABC QD for 48 weeks.

 This study will include screening, treatment and follow-up periods. Screening period up to 28
 days includes initial visits at Day -28 (screening) and Day -14 (switch to rifabutin). The
 second visit will be required if patient is initially on rifampin-based TB regimen that will
 need to be switched to rifabutin-based regimen.

 Patients receiving rifampin-containing TB therapy will be switched to rifabutin (300 mg
 daily) a minimum of 14 days prior to initiation of antiretroviral therapy. Patients must not
 have received more than 45 days of tuberculosis therapy.

 Treatment period from Day 1 to Week 48 includes 7 visits and a follow-up period (2-4 weeks
 after the Week 48 visit or Withdrawal visit) includes one visit for resolution of ongoing AEs
 and new SAEs. Patients will therefore have 10 scheduled assessments: screening (Day -28; Day
 -14), baseline (Day 1), Weeks 4, 8, 12, 24, 36, and 48, and follow-up visit.
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