HIV, HIV-1, Human Immunodeficiency Virus
Conditions
Keywords
Phase 2, Phase II, Randomized, Controlled, Comparator, Partially Blind, Protease Inhibitors, Integrase Inhibitors, Antiviral Agents, Antiretroviral Agents, ART, ARV, Highly Activity Antiretroviral Therapy, HAART, Treatment Experienced
Brief summary
The purpose of this study is to evaluate the non-inferiority of ritonavir-boosted GS-9137 relative to a ritonavir-boosted Comparator Protease Inhibitor when used as part of combination antiretroviral regimens in subjects who have failed, or are failing, protease inhibitor therapy.
Interventions
DRUGGS-9137 - A Novel HIV-1 Integrase Inhibitor
Sponsors
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* HIV RNA greater than or equal to 1000 c/mL. * Failed/Failing protease inhibitor based antiretroviral therapy. * Stable antiretroviral therapy for greater than or equal to 30 days prior to screening. * Negative Serum Pregnancy Test. * GFR by Cockcroft Gault greater than or equal to 80 mL/min. * AST & ALT less than or equal to 2.5x ULN. * Total Bilirubin less than or equal to 1.5 mg/dL. * Albumin greater than 3.5 mg/dL. * Prothrombin Time INR 1.0-1.4 * Platelets greater than or equal to 50,000. * Hemoglobin greater than or equal to 8.0 mg/dL. * Absolute Neutrophil Count greater than or equal to 1000.
Exclusion criteria
* New AIDS defining condition within 30 days of baseline. * Prior treatment with HIV-1 integrase inhibitor (except patients from 183-101). * Ascites or encephalopathy. * Breast Feeding. * Cancer Diagnosis (besides Kaposi Sarcoma or Basal Cell Carcinoma).
Countries
Puerto Rico, United States
Outcome results
None listed