Clinical trial NCT00298350: Ritonavir-Boosted GS-9137 vs. Ritonavir-Boosted Protease Inhibitor(s) in Combination With Background ART.
Official title: Phase 2 Study of the Treatment of Antiretroviral Treatment-Experienced Subjects Comparing Ritonavir-Boosted GS-9137 (GS-9137/r) vs. a Comparator Ritonavir-Boosted Protease Inhibitor (CPI/r) in Combination With Background ART.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV
HIV-1
Human Immunodeficiency Virus
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
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2006-03-02
Enrollment: 278
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Beverley Hills
country: United States
state: California
city: Fountain Valley
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Newport Beach
country: United States
state: California
city: Oakland
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Stanford
country: United States
state: California
city: Sunnyvale
country: United States
state: California
city: Torrance
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Norwalk
country: United States
state: Connecticut
city: Washington
country: United States
state: District of Columbia
city: Atlantis
country: United States
state: Florida
city: Fort Lauderdale
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: North Miami Beach
country: United States
state: Florida
city: North Palm Beach
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Vero Beach
country: United States
state: Florida
city: Decatur
country: United States
state: Georgia
city: Macon
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Springfield
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: St. Louis
country: United States
state: Missouri
city: Henderson
country: United States
state: Nevada
city: Hillsborough
country: United States
state: New Jersey
city: Santa Fe
country: United States
state: New Mexico
city: Albany
country: United States
state: New York
city: Manhasset
country: United States
state: New York
city: New York City
country: United States
state: New York
city: Huntersville
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Hershey
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Columbia
country: United States
state: South Carolina
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Annandale
country: United States
state: Virginia
city: Hampton
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Tacoma
country: United States
state: Washington
city: Milwaukee
country: United States
state: Wisconsin
city: San Juan
country: Puerto Rico
city: Santurce
country: Puerto Rico
Study officials:
References:
citation: Zolopa AR, Berger DS, Lampiris H, Zhong L, Chuck SL, Enejosa JV, Kearney BP, Cheng AK. Activity of elvitegravir, a once-daily integrase inhibitor, against resistant HIV Type 1: results of a phase 2, randomized, controlled, dose-ranging clinical trial. J Infect Dis. 2010 Mar 15;201(6):814-22. doi: 10.1086/650698.