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Sponsored by: |
Avexa |
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Information provided by: | Avexa |
ClinicalTrials.gov Identifier: | NCT00612898 |
Apricitabine is a new NRTI which is active against drug-resistant HIV. NRTIs are often included as part of patients' treatment, but many HIV-infected patients develop resistance to commonly used NRTIs such as lamivudine (3TC) and emtricitabine (FTC). This study will examine whether including apricitabine as part of patients' treatment is more effective than including lamivudine,when patients change treatment because of drug resistance.
Condition | Intervention | Phase |
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HIV Infections |
Drug: apricitabine Drug: lamivudine |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2b/3, Randomized, Double Blind, Dose Confirming Study of the Safety, Efficacy and Tolerability of Apricitabine Versus Lamivudine in Treatment-Experienced HIV-1 Infected Patients With the M184V/I Mutation in Reverse Transcriptase |
Estimated Enrollment: | 970 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
800mg BID apricitabine plus optimised background
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Drug: apricitabine
800mg BID apricitabine orally for 48 weeks
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2: Experimental
1200mg BID apricitabine plus optimised background
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Drug: apricitabine
1200mg BID apricitabine orally for 48 weeks
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3: Active Comparator
150mg BID lamivudine plus optimised background
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Drug: lamivudine
150mg BID lamivudine orally for 48 weeks
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ATC has potent antiviral activity both in vitro (against wild-type HIV-1 and HIV-1 with mutations in reverse transcriptase that confer resistance to NRTIs), and in clinical studies in both treatment-naïve and treatment-experienced patients with M184V, including in the presence of additional NRTI mutations in reverse transcriptase.
The M184V mutation is most commonly present amongst patients failing regimens containing either of the two deoxycytidine analogs lamivudine and emtricitabine. Whilst lamivudine therapy is often maintained in patients harboring the M184V mutation in some settings, there are no deoxycytidine analogs currently available that effectively suppress replication of HIV-1 containing the M184V/I mutation, particularly in the presence of other additional NRTI mutations.
The purpose of this study is to extend the efficacy and safety established in study AVX-201 of ATC in patients who are HIV-1 infected and have failed treatment with lamivudine or emtricitabine and have confirmed M184V/I mutation. Patients to be enrolled will be failing their current lamivudine- or emtricitabine-containing regimen and therefore have limited remaining NRTI treatment options. This study will investigate whether it is possible to improve control of HIV-1 viral replication by including ATC within a treatment experienced patient's new optimized background regimen following ART treatment failure.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Mark Fisher | 4153981906 ext 217 | mfisher@avexa.com.au |
Contact: Sarah M Moore, Ph D | +61 3 9208 4300 ext 4074 | smoore@avexa.com.au |
United States, Alabama | |
UAB, 845 19th St South, South Beville Biomedical Research Building | Recruiting |
Birmingham, Alabama, United States, 35294-2170 |
Study Director: | Susan W Cox, Ph D | Avexa Ltd |
Principal Investigator: | Michael Saag, MD | UAB Center for AIDS Research |
Responsible Party: | Avexa Ltd ( VP, Drug Development ) |
Study ID Numbers: | AVX-301 |
Study First Received: | January 30, 2008 |
Last Updated: | May 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00612898 |
Health Authority: | United States: Food and Drug Administration; Argentina: Human Research Bioethics Committee; Australia: Human Research Ethics Committee; Belgium: Directorate general for the protection of Public health: Medicines; Brazil: Ministry of Health; France: Afssaps - French Health Products Safety Agency; Germany: Ministry of Health; Portugal: Ethics Committee for Clinical Research; South Africa: Department of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Italy: The Italian Medicines Agency; Israel: Ministry of Health; Canada: Health Canada; Guatemala: Health ministry; India: Ministry of Health; Russia: Pharmacological Committee, Ministry of Health; Thailand: Food and Drug Administration; Peru: Ministry of Health; Mexico: Ministry of Health; Uganda: Ministry of Health |
HIV infection Drug resistance Reverse transcriptase inhibitor Nucleoside analogue treatment experienced |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Lamivudine Retroviridae Infections Immunologic Deficiency Syndromes |
Anti-Infective Agents Communicable Diseases RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |