Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Incyte Corporation |
---|---|
Information provided by: | Incyte Corporation |
ClinicalTrials.gov Identifier: | NCT00300573 |
The study will compare the safety and efficacy of an investigation nucleoside analog reverse transcriptase inhibitor (NRTI), dexelvucitabine (DFC), to an approved NRTI, lamivudine (3TC) in HIV treatment-experienced patients who are resistant to 3 classes of antiretroviral therapies (NRTIs, PIs and NNRTIs).
Patients meeting eligibility requirements will have a new 'optimized' background regimen (OBR) selected for them by their investigator based on prior ARV treatment history and the results of HIV genotype and phenotype tests performed during the screening period. In addition to treatment with the new OBR, patients will be randomized to receive treatment with DFC or 3TC in a blinded fashion. There is a 50 percent chance a patient will receive DFC or 3TC. Treatment in the study may continue for up to 96 weeks. Patients with an inadequate response to therapy after 16 weeks will have the option to change their OBR and the option to switch to receive the other study medication (i.e., DFC to 3TC or 3TC to DFC).
Condition | Intervention | Phase |
---|---|---|
HIV Infections Human Immunodeficiency Virus |
Drug: Dexelvucitabine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Phase II Study Comparing the Anti-Retroviral Safety and Efficacy of Dexelvucitabine (DFC) 200 Mg Once Daily to Lamivudine (3TC) 300 Mg Once Daily in Addition to Optimized Background Therapy in HIV-1 Infected Subjects Who Have Failed and/or Harbor HIV With Resistance Mutations to NRTIs, PIs, and NNRTIs |
Estimated Enrollment: | 250 |
Study Start Date: | February 2006 |
The study will compare the safety and efficacy of an investigational nucleoside analog reverse transcriptase inhibitor (NRTI), dexelvucitabine (DFC) 200 mg once daily, to an approved NRTI, lamivudine (3TC) 300 mg once daily in treatment experienced patients with HIV that is resistant to 3 classes of antiretroviral therapies (NRTIs, PIs and NNRTIs). Patients meeting eligibility requirements will have a new 'optimized' background regimen (OBR) selected for them based on prior treatment history, and results of HIV genotype and phenotype performed during screening. In addition to the OBR patients will be randomized to receive at at one to one ratio DFC or 3TC in a blinded fashion. The OBR may include any approved HIV treatments except 3TC, FTC, ddI, d4T and ddC. Medications available through expanded access may also be available to selected patients. Treatment in the study will continue for up to 96 weeks with primary endpoints at 24 and 48 weeks of therapy. Patients with an inadequate response to therapy after 16 weeks will have the option to change their OBR and the option to switch study medication (DFC to 3TC or 3TC to DFC). A total of 250 patients will be enrolled.
Ages Eligible for Study: | 16 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Women of childbearing potential may be enrolled following a negative serum pregnancy test. If participating in activity that could lead to pregnancy, women shall agree to use TWO forms of contraception as listed in # 1-4 below (at least one must be a barrier method) while receiving protocol-specified medication and for 2 months after stopping the medication.
Demonstrate evidence of failure of at least 3 drug classes, defined as #s 1-3 below:
Exclusion Criteria:
Subjects with the following laboratory parameters within 35 days prior to first dose of study medication:
United States, California | |
Long Beach, California, United States, 90813 | |
United States, Florida | |
Brandon, Florida, United States | |
Miami, Florida, United States | |
Fort Lauderdale, Florida, United States | |
Plantation, Florida, United States, 33317 | |
United States, Georgia | |
Atlanta, Georgia, United States, 30309 | |
United States, Illinois | |
Chicago, Illinois, United States, 60657 | |
United States, New York | |
New York, New York, United States, 10018 | |
United States, Oregon | |
Portland, Oregon, United States, 97209 | |
United States, Texas | |
Dallas, Texas, United States | |
Puerto Rico | |
San Juan, Puerto Rico, 00909 |
Study ID Numbers: | INCB 08721-204, EudraCT #:2006-000096-16 |
Study First Received: | March 7, 2006 |
Last Updated: | April 3, 2006 |
ClinicalTrials.gov Identifier: | NCT00300573 History of Changes |
Health Authority: | United States: Food and Drug Administration |
dexelvucitabine DFC Treatment Experienced HIV-1 |
Virus Diseases Sexually Transmitted Diseases, Viral Anti-Retroviral Agents HIV Infections Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome |
Lamivudine Antiviral Agents Retroviridae Infections Immunologic Deficiency Syndromes Protease Inhibitors Reverse Transcriptase Inhibitors |
Anti-Infective Agents RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Infection Antiviral Agents Pharmacologic Actions |
Immunologic Deficiency Syndromes Reverse Transcriptase Inhibitors Virus Diseases Anti-Retroviral Agents HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections Nucleic Acid Synthesis Inhibitors |