Raltegravir + Lamivudine/Abacavir in HIV/Tuberculosis Co-Infected Patients
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections Tuberculosis |
Drug: Raltegravir; Abacavir/Lamivudine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 10 |
| Study Start Date: | October 2010 |
| Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
-
Drug: Raltegravir; Abacavir/Lamivudine
- Isentress®
- Epzicom®
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Russian Federation | |
| Central Research Institute of Epidemiology | Recruiting |
| Moscow, Russian Federation, 111123 | |
| Contact: Alexey V. Kravtchenko, PhD +74953660518 alexey-kravtchenko@yandex.ru | |
| Sub-Investigator: Alexey V. Kravtchenko, PhD | |
| Principal Investigator: | Vadim V. Pokrovsky, PhD | Central Research Institute of Epidemiology |
More Information
No publications provided
| Responsible Party: | Alexey Kravtchenko/Professor, Central Institute of Epidemiology, Moscow, Russia |
| ClinicalTrials.gov Identifier: | NCT01059422 History of Changes |
| Other Study ID Numbers: | RAL/ABC/3TC - HIV/TB |
| Study First Received: | January 28, 2010 |
| Last Updated: | May 5, 2011 |
| Health Authority: | Russia: Ethics Committee |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Tuberculosis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Mycobacterium Infections Actinomycetales Infections |
Gram-Positive Bacterial Infections Bacterial Infections Lamivudine Abacavir Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |
ClinicalTrials.gov processed this record on March 03, 2013
