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Sponsored by: |
Gilead Sciences |
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Information provided by: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT00224458 |
To characterize the risks (safety and tolerability), effectiveness (continued viral load suppression and CD4 changes), and benefits (safety, tolerability, adherence, general satisfaction with the treatment regimen and QoL), of switching from a Combivir (BID) / efavirenz (QD) regimen to an all QD regimen of Truvada/efavirenz.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Truvada Drug: efavirenz |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Combination of Efavirenz & Truvada (COMET Study): Phase 4 Evaluation of Switching Twice Daily Combivir to Once-Daily Regimen Co-Formulated Truvada in Virologically Suppressed HIV Infected Patients Taking Efavirenz. |
Estimated Enrollment: | 400 |
Study Start Date: | September 2004 |
Study Completion Date: | February 2006 |
The objectives of this study are to characterize the risks (safety and tolerability), effectiveness (continued viral load suppression and CD4 changes), and benefits (safety, tolerability, adherence, general satisfaction with the treatment regimen and QoL), of switching from a Combivir (BID) / efavirenz (QD) regimen to an all QD regimen of Truvada/efavirenz.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Male: (140 - age in years) x (wt in kg) divided by 72 x (serum creatinine in mg/dL) = CLCr (mL/min.
Female: (140 - age in years) x(wt in kg) divided by 72 x (serum creatinine in mg/dL) x 0.85 = CLCr (mL/min).
Exclusion Criteria:
Nephrotoxic agents (aminoglycoside antibiotics, IV amphotericin B, cidofovir, cisplatin, foscarnet, IV pentamidine, other agents with significant nephrotoxic potential):
Drugs that interact with efavirenz:
Responsible Party: | Gilead Sciences ( John Flaherty, Director, Medical Affairs ) |
Study ID Numbers: | GS-US-164-0107 |
Study First Received: | September 19, 2005 |
Last Updated: | April 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00224458 |
Health Authority: | United States: Food and Drug Administration |
Treatment Experienced HIV-1 |
Virus Diseases Efavirenz Sexually Transmitted Diseases, Viral HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
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 |