Single Tablet Regimen (STR) Simplification Study for HIV-1 Infected Patients - Full Text View

Purpose

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	Intervention	Phase
HIV Infections	Drug: Efavirenz (EFV), Emtricitabine (FTC), Tenofovir DF (TDF)	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Emtricitabine Tenofovir Efavirenz Tenofovir Disoproxil Fumarate

U.S. FDA Resources

Further study details as provided by Gilead Sciences:

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


Estimated Enrollment:	300
Study Start Date:	July 2006
Study Completion Date:	January 2008
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Eligibility


Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Genders Eligible for Study:	Both
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.
HAART must consist of either:
1. A PI (with or without ritonavir) + at least 2 NRTIs or
2. 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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00365612

Show 56 Study Locations

Sponsors and Collaborators

Gilead Sciences

Bristol-Myers Squibb

Investigators


Study Director:	John Flaherty	Gilead Sciences

More Information

Additional Information:

ATRIPLA website This link exits the ClinicalTrials.gov site

Gilead Sciences website This link exits the ClinicalTrials.gov site

Bristol-Myers Squibb website This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hodder SL, Mounzer K, Dejesus E, Ebrahimi R, Grimm K, Esker S, Ecker J, Farajallah A, Flaherty JF; AI266073 Study Group. Patient-reported outcomes in virologically suppressed, HIV-1-Infected subjects after switching to a simplified, single-tablet regimen of efavirenz, emtricitabine, and tenofovir DF. AIDS Patient Care STDS. 2010 Feb;24(2):87-96. doi: 10.1089/apc.2009.0259.

Dejesus E, Young B, Morales-Ramirez JO, Sloan L, Ward DJ, Flaherty JF, Ebrahimi R, Maa JF, Reilly K, Ecker J, McColl D, Seekins D, Farajallah A; AI266073 Study Group. Simplification of antiretroviral therapy to a single-tablet regimen consisting of efavirenz, emtricitabine, and tenofovir disoproxil fumarate versus unmodified antiretroviral therapy in virologically suppressed HIV-1-infected patients. J Acquir Immune Defic Syndr. 2009 Jun 1;51(2):163-74. doi: 10.1097/QAI.0b013e3181a572cf.


Responsible Party:	John Flaherty, Director, Medical Affairs, Gilead Sciences
ClinicalTrials.gov Identifier:	NCT00365612 History of Changes
Other Study ID Numbers:	AI266073
Study First Received:	August 16, 2006
Last Updated:	April 9, 2008
Health Authority:	United States: Institutional Review Board

Keywords provided by Gilead Sciences:


HIV HIV-1 AIDS Human Immunodeficiency Virus HIV-1 Infection

Additional relevant MeSH terms:


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 Efavirenz Emtricitabine 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

ClinicalTrials.gov processed this record on September 27, 2016