Clinical Trials

A4001078

Sponsor:
Pfizer

Study Title:
CLOSED FOR ACCRUAL. A Pilot Study Of A Novel Nucleoside-Free Treatment Regimen, Maraviroc + Ritonavir Boosted Atazanavir, In Treatment Naive HIV-Infected Patients

Summary:
This is a pilot study to examine if the novel treatment regimen maraviroc plus boosted atazanavir can be expected to be safe and efficacious in treatment naive HIV infected patients. Based on the results from this study, a confirmatory study may be conducted.

Phase:
Phase 3

Study Design:
Treatment, Open Label, Parallel Assignment, Safety/Efficacy Study    

Eligibility Criteria:

• Ages Eligible for Study: 16 Years and older
• Genders Eligible for Study:  Both
• Accepts Healthy Volunteers:  No

Inclusion Criteria:

• HIV-1 RNA viral load of ≥1,000 copies/mL measured at the Screening Visit.
• CD4 count ≥100 cells/mm3 at Screening.
• Have only R5 HIV-1 at Screening as verified by the Monogram Bioscience TrofileŽ assay with enhanced sensitivity.

Exclusion Criteria:

• Prior treatment with any other HIV antiretroviral therapy for more than 14 days at any time.
• Acute illness or Acute HIV-related OI
• Renal Insuffiency

Drugs/Treatment Provided:

• Arm A: Experimental Drug: maraviroc 150 mg QD + atazanavir/ritonavir 300/100mg QD
• Arm B: Experimental Drug: maraviroc atazanavir/ritonavir 300/100 mg QD +emtricitabine/tenofovir 200/300mg QD

Compensation:
$20 per on study clinic visit

Study Duration: 48 weeks

Principal Investigator: Donna Mildvan, M.D.

Study Location: Beth Israel Medical Center

Infectious Diseases/AIDS Clinical Trials Unit

350 East 17th Street, 3rd floor

New York, NY, 10003

Contact Information: Phone: 212-420-4519 or 800-483-7339 Email

ALL TRIALS IN THIS CATEGORY

Click highlighted ID code below to view individual trial details.

GS-US-216-0114
A Phase 3, Randomized, Double-Blind study to Evaluate the Safety and Efficacy of GS-9350-boosted Atatzanavir Versus Ritonavir-boosted Atazanavir each administered with Emtricitabine/Tenofovir in HIV-1 Infected, Antiretroviral treatment Naīve Adults

GS-US-236-0103
Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Emtricitabine/Tenofovir/GS-9350 Versus Ritonavir-Boosted Atazanavir Plus Emtricitabine/Tenofovir in HIV-1 Infected, Antiretroviral Treatment-Naīve Adults

A4001078
CLOSED FOR ACCRUAL. A Pilot Study Of A Novel Nucleoside-Free Treatment Regimen, Maraviroc + Ritonavir Boosted Atazanavir, In Treatment Naive HIV-Infected Patients

TMC278-TiDP6-C209
CLOSED TO ACCRUAL. A Clinical Trial in Treatment Naīve HIV-1 Patients Comparing TMC278 to Efavirenz in Combination With Tenofovir + Emtricitabine.

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