Single Tablet Regimen (STR) Simplification Study for HIV-1 Infected Patients
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| ClinicalTrials.gov Identifier: NCT00365612 |
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Recruitment Status :
Completed
First Posted : August 17, 2006
Last Update Posted : April 10, 2008
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Sponsor:
Gilead Sciences
Collaborator:
Bristol-Myers Squibb
Information provided by:
Gilead Sciences
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Brief Summary:
To compare the effectiveness (efficacy, safety & tolerability) of a Single Tablet Regimen of efavirenz/emtricitabine/tenofovir DF to subjects continuing on unmodified HAART as measured by the proportion of patients who maintain viral load (HIV-1 RNA) <200 copies/mL at Week 48.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infections | Drug: Efavirenz (EFV), Emtricitabine (FTC), Tenofovir DF (TDF) | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 300 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Phase IV, Open-Label, Randomized, Multicenter Study Evaluating Efficacy and Tolerability of Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir DF Compared to Unmodified HAART in HIV-1 Infected Subjects Who Have Achieved Virological Suppression on Their HAART Regimen |
| Study Start Date : | July 2006 |
| Actual Primary Completion Date : | October 2007 |
| Actual Study Completion Date : | January 2008 |
Primary Outcome Measures :
- Primary: Proportion of patients with HIV-1 RNA levels <200 copies/mL at Week 48
- Safety Outcome Measures: Adverse Events, Laboratory Tests
- Outcomes Research Measures: Quality of life, adherence, preference of medication, perceived ease of regimen, HIV symptoms
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- HIV-1 positive patients who have maintained an HIV-1 viral load <200 copies/mL, for at least 3 months.
- Patients must be on their first HAART or have documented viral suppression on a PI-based regimen at the time of any prior change in therapy.
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HAART must consist of either:
- A PI (with or without ritonavir) + at least 2 NRTIs or
- An NNRTI + at least 2 NRTIs.
- Negative serum pregnancy test.
Exclusion Criteria:
- Patients who have taken any NNRTI prior to their current therapy.
- Patients who have taken a NRTI-only therapy for greater than 7 days prior to their current therapy.
- Patients who are currently taking EFV+FTC+TDF.
- Patients who have a creatinine clearance of <60 mL/min by Cockcroft-Gault estimation.
- Patients who have experienced virologic failure with any previous ARV therapy.
- Patients who have documented resistance to any of the study agents at any time in the past.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00365612
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Sponsors and Collaborators
Gilead Sciences
Bristol-Myers Squibb
Investigators
| Study Director: | John Flaherty | Gilead Sciences |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | John Flaherty, Director, Medical Affairs, Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT00365612 History of Changes |
| Other Study ID Numbers: |
AI266073 |
| First Posted: | August 17, 2006 Key Record Dates |
| Last Update Posted: | April 10, 2008 |
| Last Verified: | April 2008 |
Keywords provided by Gilead Sciences:
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HIV HIV-1 AIDS Human Immunodeficiency Virus HIV-1 Infection |
Additional relevant MeSH terms:
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HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Tenofovir Emtricitabine Efavirenz Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Antiviral Agents |
Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Anti-HIV Agents Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 Enzyme Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP3A Inducers |