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Sponsors and Collaborators: |
Orlando Immunology Center GlaxoSmithKline |
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Information provided by: | Orlando Immunology Center |
ClinicalTrials.gov Identifier: | NCT00312169 |
This is a multicenter, open-label, non-randomized, dual-arm pilot study to investigate the prevalence of the reverse transcriptase (RT) resistance mutations, K65R/x or L74V/x, in HIV-1 plasma from subjects experiencing confirmed first-time incomplete virologic suppression during treatment with an initial antiretroviral (ARV) regimen consisting of at least 12 weeks of TDF or ABC + emtricitabine (FTC) or lamivudine (3TC) + non-nucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI). Subjects will be followed until a substantial loss of virologic or immunologic control requires a treatment switch. Confirmed first-time incomplete virologic suppression is defined as an initial plasma HIV-1 RNA response < 400 copies/mL, and subsequent virologic rebound > 400 copies/mL measured at two consecutive times.
Subjects will have a screening genotype to establish adherence to their non-suppressive TDF- or ABC-containing regimen by the presence of M184V (or other treatment-related primary) mutation and to demonstrate that the evolution of treatment-emergent RT mutations can be characterized.
Twenty subjects (a maximum of 10 per arm) will be enrolled at 10-20 United States (U.S.) sites. If fewer than 20 subjects can be enrolled, the study may be discontinued early by the sponsor. Equal numbers of subjects on Arm A versus Arm B will be a goal.
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Evolution of L74V or K65R Mutations in VIremic Subjects on TDF or ABC (EVITA) |
Estimated Enrollment: | 20 |
Study Start Date: | April 2006 |
Study Completion Date: | May 2008 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Routine labs as demonstrated by last available lab panel to be:
Exclusion Criteria:
United States, California | |
Tarzana Treatment Center | |
Tarzana, California, United States, 91356 | |
Shared Medical Research Foundation | |
Tarzana, California, United States, 91356 | |
Special Services Adult HIV Clinic | |
Fresno, California, United States, 93702 | |
AltaMed Health Services Corporation | |
Los Angelos, California, United States, 90022 | |
United States, Florida | |
Orlando Immunology Center | |
Orlando, Florida, United States, 32803 | |
United States, Illinois | |
Northstar Medical Center | |
Chicago, Illinois, United States, 60657 | |
United States, Michigan | |
Paul Benson, DO, PC | |
Berkley, Michigan, United States, 48072 | |
United States, New York | |
Ricky Hsu, MD | |
New York, New York, United States, 10011 | |
United States, Pennsylvania | |
Temple University School of Medicine, Section of Infectious Diseases | |
Philadelphia, Pennsylvania, United States, 19140 | |
United States, South Carolina | |
Greenville Hospital System Infectious Disease Associates | |
Greenville, South Carolina, United States, 29605 | |
United States, Texas | |
Nicholas C. Bellos, MD PA and Associates | |
Dallas, Texas, United States, 75204 |
Study Director: | Edwin DeJesus, MD, FACP | OIC |
Study ID Numbers: | COL105034 (EVITA), EVITA |
Study First Received: | April 5, 2006 |
Last Updated: | May 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00312169 |
Health Authority: | United States: Institutional Review Board |
HIV NNRTI Incomplete virologic suppression treatment experienced |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome |
Tenofovir Abacavir Retroviridae Infections Immunologic Deficiency Syndromes Tenofovir disoproxil |
Anti-Infective Agents 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 |