HIV Infections Clinical Trial
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
Verified date | May 2011 |
Source | Central Institute of Epidemiology, Moscow, Russia |
Contact | n/a |
Is FDA regulated | No |
Health authority | Russia: Ethics Committee |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | |
Est. primary completion date | October 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Russian Federation | Central Research Institute of Epidemiology | Moscow |
Lead Sponsor | Collaborator |
---|---|
Central Institute of Epidemiology, Moscow, Russia | Merck Sharp & Dohme Corp. |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of subjects with plasma HIV-1 RNA <50 copies/ml by the Time to Loss of Virologic Response (TLOVR) algorithm | 48 week | No |
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