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Pfizer A4001095

Study ID: A4001095

Sponsor: ViiV Healthcare/Pfizer

Title: NOW OPEN. A Multicenter, Randomized, Double Blind, Comparative Trial Of Maraviroc + Darunavir/Ritonavir Versus Emtricitabine/Tenofovir +Darunavir/Ritonavir For The Treatment Of Antiretroviral-Naïve HIV Infected Patients With Ccr5 Tropic HIV 1

Summary:
The purpose of this study is to assess whether maraviroc administered once daily is non-inferior to emtricitabine/tenofovir also administered once daily each in combination with darunavir/ritonavir in the treatment of antiretroviral-naive patients as evaluated at Week 48 of treatment.

Phase #: 3

Study Design: Randomized Double Blind Treatment Efficacy Study

Eligibility Criteria:

Inclusion Criteria:

• Plasma HIV-1 RNA equal to or greater than 1,000 copies/mL measured at the Screening Visit.
• CD4 count equal to or greater than 100 cells/mm3 at Screening.
• Have only R5 HIV 1 at Screening as verified by a randomized tropism assay.
  

Exclusion Criteria:

• Prior treatment with any other HIV antiretroviral therapy for more than 14 days at any time.
  
• Any evidence of genotypic/phenotypic resistance to darunavir, tenofovir, and emtricitabine.
• CXCR4 using virus detected using randomized tropism determination or repeated failure to obtain an interpretable tropism result.

Drugs/Treatment Provided:

Duration: 48 weeks

Compensation to Participant: $20

Principal Investigator: Donna Mildvan, MD

Study Location:
Beth Israel Medical Center
AIDS Clinical Trials Unit
350 East 17th Street, 3rd Floor
New York, NY 10003

Contact Information:
Ph: 212-420-4519 or 800-483-7339

Email: Trials@BethIsraelNY-HIVtrials.org

ALL TRIALS IN THIS CATEGORY

Click highlighted ID code below to view individual trial details.

Gilead US- 264 – 0110:

NO LONGER RECRUITING: A Phase 3B, Randomized, Open-label Study to Evaluate the Safety and Efficacy of a Single Tablet Regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Compared With a Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV 1 Infected, Antiretroviral Treatment-Naïve Adults

Pfizer A4001095:

NOW OPEN: A Multicenter, Randomized, Double-blind, Comparative Trial of Marviroc + Darunavir/Ritonavir Versus Emtricitabine/Tenofovir + Darunavir/Ritonavir For The Treatment Of Antiretroviral – Naïve HIV – Infected Patients With CCR5 – Tropic HIV-1

GS-US-216-0114:

NO LONGER RECRUITING- Phase 3. To evaluate the safety and efficacy of GS-9350-boosted Atatzanavir Versus Ritonavir-boosted Atazanavir each administered with Emtricitabine/Tenofovir

Pfizer A4001078:

NO LONGER RECRUITING. No Prior Treatment. Pilot study of Maraviroc + ATV/R vs. ATV/r + Truvada in HIV ARV Naïve, R5 Positive Patients

Call toll-free: 800.483.7339