Raltegravir + Lamivudine/Abacavir in HIV/Tuberculosis Co-Infected Patients
Recruitment status was: Recruiting
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.
|HIV Infections Tuberculosis||Drug: Raltegravir; Abacavir/Lamivudine||Phase 4|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Efficacy and Safety of an Initial Regimen Raltegravir (RAL) + Lamivudine/Abacavir Fixed-Dose Combination (3TC/ABC FDC) for 48 Weeks in ART-naïve, HIV/TB Co-Infected Adult Subjects Receiving Rifabutin-containing, 1-line Anti-TB Therapy|
- Proportion of subjects with plasma HIV-1 RNA <50 copies/ml by the Time to Loss of Virologic Response (TLOVR) algorithm [ Time Frame: 48 week ]
|Study Start Date:||October 2010|
|Estimated Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Drug: Raltegravir; Abacavir/Lamivudine
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01059422
|Central Research Institute of Epidemiology||Recruiting|
|Moscow, Russian Federation, 111123|
|Contact: Alexey V. Kravtchenko, PhD +74953660518 firstname.lastname@example.org|
|Sub-Investigator: Alexey V. Kravtchenko, PhD|
|Principal Investigator:||Vadim V. Pokrovsky, PhD||Central Research Institute of Epidemiology|