Combivir And Maraviroc In Antiretroviral Naive Subjects In Russia (A4001101)
This study is currently recruiting participants.
Verified April 2013 by ViiV Healthcare
Sponsor:
ViiV Healthcare
Collaborator:
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT01275625
First received: January 11, 2011
Last updated: April 29, 2013
Last verified: April 2013
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Purpose
One hundred subjects in Russia will be treated with a combination of Combivir (zidovudine and lamivudine) and maraviroc as their first line HIV therapy. The aim is to assess the efficacy and safety of this combination in a Russian population of patients.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV |
Drug: HIV therapy |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multicenter, Open Label Study Of Maraviroc, Zidovudine And Lamivudine Twice Daily For The Treatment Of Antiretroviral Naïve HIV-Infected Patients With R5 HIV-1 In Russia |
Resource links provided by NLM:
Further study details as provided by ViiV Healthcare:
Primary Outcome Measures:
- Proportion of patients with a viral load <50 copies/mL [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety and tolerability of the regimen of combivir and maraviroc in this subject population [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
- To determine the magnitude of changes in CD4+ and CD8+ cell counts and CD4+/CD8+ ratio from baseline [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
- To examine the evolution of viral resistance and/or tropism in virologic failure subjects infected predominantly with subtype A recombinants of HIV 1. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 110 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | April 2013 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment
Single arm study of combivir and maraviroc for 48 weeks
|
Drug: HIV therapy
Combivir one tablet BD with maraviroc 300mg BD for 48 weeks
Other Name: Selzentry, Celsentri
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Over 18 years of age.
- R5 HIV infection on screening tropism test.
- Viral load >1,000 copies/mL.
- Never previously treated with anti-HIV medicines.
Exclusion Criteria:
- Previously treated with anti-HIV medicines.
- Hepatitis B co-infection.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01275625
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Locations
| Russian Federation | |
| Regional Center on AIDS and Infectious Diseases Prophylaxis and Control | Active, not recruiting |
| Krasnoyarsk, Russian Federation, 660049 | |
| Federal scientific and methodological center on AIDS prophylaxis and control | Recruiting |
| Moscow, Russian Federation, 105275 | |
| Moscow regional center on AIDS and infectious diseases prophylaxis and control | Recruiting |
| Moscow, Russian Federation, 129110 | |
| Regional Center on AIDS and Infectious Diseases Prophylaxis and Control | Recruiting |
| Nizhnij Novgorod, Russian Federation, 603005 | |
| Saint-Petersburg Center on AIDS and Infectious Diseases Prophylaxis and Control | Recruiting |
| Saint-Petersburg, Russian Federation, 190103 | |
| Federal State Institution Republican clinical infectious hospital of Roszdrav | Recruiting |
| Saint-Petersburg, Russian Federation, 196645 | |
| Smolensk Center on AIDS and infectious diseases prophylaxis and control | Recruiting |
| Smolensk, Russian Federation, 214006 | |
| Volgograd Regional Center on AIDS and Infectious Diseases Prophylaxis and Control | Terminated |
| Volgograd, Russian Federation, 400040 | |
Sponsors and Collaborators
ViiV Healthcare
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | ViiV Healthcare |
| ClinicalTrials.gov Identifier: | NCT01275625 History of Changes |
| Other Study ID Numbers: | A4001101 |
| Study First Received: | January 11, 2011 |
| Last Updated: | April 29, 2013 |
| Health Authority: | Russia: Pharmacological Committee, Ministry of Health |
Keywords provided by ViiV Healthcare:
|
maraviroc naive hiv zidovudine |
lamivudine combivir Clade A |
Additional relevant MeSH terms:
|
Zidovudine Lamivudine Lamivudine, zidovudine drug combination Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Reverse Transcriptase Inhibitors |
Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |
ClinicalTrials.gov processed this record on May 19, 2013