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QuintilesIMS
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Generated: December 13, 2018

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CLINICAL TRIALS PROFILE FOR ATRIPLA

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Clinical Trials for Atripla

Trial ID Title Status Sponsor Phase Summary
NCT00432016 Safety, Tolerance, Pharmacokinetic and Antiviral Study of Amdoxovir in Combination With Zidovudine in Adults With HIV Completed RFS Pharma, LLC Phase 1/Phase 2 The purpose of this study is to determine the short term safety, tolerance, and antiviral effect of zidovudine (AZT) and amdoxovir (AMDX, DAPD) in combination, and whether the dosage for AZT can be reduced, potentially decreasing side effects, while maintaining antiviral effects. Study hypothesis: DADP in combination with AZT is safe and effective, and AZT dosing may be reduced, resulting in lower levels of AZT-monophosphate associated with toxicity and maintaining levels of AZT-triphosphate associated with efficacy.
NCT00573001 Evaluation of 4 New Simplified Antiretroviral Treatments in Naive HIV-1 Infected Patients in Africa (ANRS 12115 DAYANA) Completed Gilead Sciences Phase 3 The goal of this trial is to demonstrate that new treatments are as effective as a reference triple-agent regimen in driving plasma viral load below the detection limit early during treatment (16 weeks). These simplified treatments involve fewer tablets and intakes, fixed-dose combinations, and also radically new strategies such as boosted protease inhibitor and tenofovir.
NCT00573001 Evaluation of 4 New Simplified Antiretroviral Treatments in Naive HIV-1 Infected Patients in Africa (ANRS 12115 DAYANA) Completed Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba Phase 3 The goal of this trial is to demonstrate that new treatments are as effective as a reference triple-agent regimen in driving plasma viral load below the detection limit early during treatment (16 weeks). These simplified treatments involve fewer tablets and intakes, fixed-dose combinations, and also radically new strategies such as boosted protease inhibitor and tenofovir.
NCT00573001 Evaluation of 4 New Simplified Antiretroviral Treatments in Naive HIV-1 Infected Patients in Africa (ANRS 12115 DAYANA) Completed Merck Sharp & Dohme Corp. Phase 3 The goal of this trial is to demonstrate that new treatments are as effective as a reference triple-agent regimen in driving plasma viral load below the detection limit early during treatment (16 weeks). These simplified treatments involve fewer tablets and intakes, fixed-dose combinations, and also radically new strategies such as boosted protease inhibitor and tenofovir.
NCT00573001 Evaluation of 4 New Simplified Antiretroviral Treatments in Naive HIV-1 Infected Patients in Africa (ANRS 12115 DAYANA) Completed French National Agency for Research on AIDS and Viral Hepatitis Phase 3 The goal of this trial is to demonstrate that new treatments are as effective as a reference triple-agent regimen in driving plasma viral load below the detection limit early during treatment (16 weeks). These simplified treatments involve fewer tablets and intakes, fixed-dose combinations, and also radically new strategies such as boosted protease inhibitor and tenofovir.
NCT00615745 ONCE - Only Nocturnal Combination Evaluation of Antiretroviral-Experienced HIV 1 Infected Subjects Switching to Atripla Completed Gilead Sciences Phase 4 A single tablet regimen (STR) of efavirenz, emtricitabine and tenofovir disoproxil fumarate (tenofovir DF) is the first complete HAART that is offered as one tablet once a day. The individual components of this HAART regimen have demonstrated efficacy and safety in HIV treatment-naive patients and offer simplification that in turn may increase adherence and improve clinical outcomes. This study aims to evaluate the effectiveness (efficacy, safety and tolerability) of a STR simplification strategy in patients on HAART who have achieved viral suppression in a real world clinical setting.
NCT00615810 ROCKET I - Randomized Open Label Switch for Cholesterol Elevation on Kivexa Evaluation Trial Completed Gilead Sciences Phase 4 This study aims to investigate whether patients switching their backbone from Kivexa to Truvada, who already have raised total cholesterol prior to switching, have an improvement in their total cholesterol after 12 weeks of treatment. If an improvement is demonstrated the study aims to show whether this has a beneficial effect on the patient's overall cardiovascular risk and long term prognosis.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Atripla

Condition Name

Condition Name for Atripla
Intervention Trials
HIV Infections 15
HIV 14
HIV-1 Infection 5
HIV Infection 5
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Condition MeSH

Condition MeSH for Atripla
Intervention Trials
HIV Infections 24
Acquired Immunodeficiency Syndrome 12
Immunologic Deficiency Syndromes 7
Communicable Diseases 4
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Clinical Trial Locations for Atripla

Trials by Country

Trials by Country for Atripla
Location Trials
United States 134
United Kingdom 12
Canada 11
Italy 8
Germany 7
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Trials by US State

Trials by US State for Atripla
Location Trials
North Carolina 8
California 8
Massachusetts 8
New York 8
Texas 6
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Clinical Trial Progress for Atripla

Clinical Trial Phase

Clinical Trial Phase for Atripla
Clinical Trial Phase Trials
Phase 4 20
Phase 3 11
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Atripla
Clinical Trial Phase Trials
Completed 28
Recruiting 6
Withdrawn 5
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Clinical Trial Sponsors for Atripla

Sponsor Name

Sponsor Name for Atripla
Sponsor Trials
Gilead Sciences 19
Merck Sharp & Dohme Corp. 10
St Stephens Aids Trust 6
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Sponsor Type

Sponsor Type for Atripla
Sponsor Trials
Industry 52
Other 39
NIH 5
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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
AstraZeneca
Harvard Business School
Cantor Fitzgerald
QuintilesIMS
Dow
Merck
Chubb
Daiichi Sankyo

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