Available Clinical Trials: No Prior HIV Treatment

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GSK ING114467

Study ID: GSK ING114467

Sponsor: ViiV

Title: NO LONGER RECRUITING: A Randomized, Double-Blind Study of the Safety and Efficacy of GSK1349572 Plus Abacavir/Lamivudine Fixed-Dose Combination Therapy Administered Once Daily Compared to Atripla Over 96 Weeks in HIV-1 Infected Antiretroviral Therapy Naive Adult Subjects

Summary: ING114467 is a Phase 3 randomized, double-blind, double dummy, active-controlled, multicenter, study conducted in approximately 788 HIV-1 infected ART-naÔve subjects. Subjects will be randomized 1:1 one of the following treatment arms: GSK1349572 50 mg plus abacavir/lamivudine fixed-dose combination once daily or Atripla once daily.

Phase #: 3

Study Design: Randomized, Double-Dummy, Double-Blind Study

Eligibility Criteria:

Inclusion Criteria:

• Screening plasma HIV-1 RNA greater than or equal to 1000 c/mL
• Antiretroviral-naÔve
• A negative HLAB*5701 allele assessment
  

Exclusion Criteria:

• Active Center for Disease and Prevention Control (CDC) Category C disease
• Malignancy within the past 5 years
• Treatment with radiation therapy, cytotoxic chemotherapeutic agents or any immunomodulator within 28 days of Screening.

Drugs/Treatment Provided:

Arm A: Assigned Interventions Experimental: GSK1349572 50mg once daily + abacavir/lamivudine as the fixed-dose combination once daily + Atripla placebo once daily

Arm B: Active Comparator: Atripla once daily + GSK1349572 placebo once daily + abacavir/lamivudine as the fixed-dose combination placebo once daily

Duration: 96 weeks

Compensation to Participant: $50 per visit

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

GSK ING114467:

NO LONGER RECRUITING. SINGLE A Randomized, Double-Blind Study of the Safety and Efficacy of GSK1349572 Plus Abacavir/Lamivudine Fixed-Dose Combination Therapy Administered Once Daily Compared to Atripla Over 96 Weeks in HIV-1 Infected Antiretroviral Therapy Naive Adult Subjects

Call toll-free: 800.483.7339