Clinical trial NCT00445146: Safety of EVG+RTV Administered With Other Antiretroviral Agents for the Treatment of HIV-1 Infection
Official title: A Phase 2, Open-Label, Multicenter Study of the Safety of Ritonavir-Boosted GS-9137 (GS-9137/r) Administered in Combination With Other Antiretroviral Agents for the Treatment of HIV-1 Infected Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: Phase 2
Open-label
Rollover
Integrase Inhibitor
Antiretroviral Agents
Highly Active Antiretroviral Activity
HAART
HIV, HIV-1, AIDS virus, Human Immunodeficiency Virus
Acquired Immune Deficiency Syndrome Virus
treatment experienced
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2007-03-08
Enrollment: 192
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to observe the long-term safety of elvitegravir (EVG) boosted with ritonavir (RTV) in combination with other antiretroviral (ARV) agents in participants who have completed a prior EVG+RTV treatment study.


Eligibility criteria: Inclusion Criteria:

* Completion of a prior EVG+RTV treatment study without treatment-limiting toxicity.
* Males and females of childbearing potential must agree to utilize effective contraception methods.
* Ability to understand and sign a written informed consent form.

Exclusion Criteria:

* Females who are pregnant or breastfeeding.
* Participation in any other clinical trial without prior approval from the Sponsor.
* Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study.
* Subjects receiving ongoing therapy with contraindicated drugs.

Primary outcomes:
measure: Percentage of Participants Experiencing Any Treatment-Emergent Study Dug-Related Adverse Event
timeFrame: Up to Week 408 plus 30 days
Secondary outcomes:
measure: Percentage of Participants Experiencing Treatment-Emergent Adverse Events
timeFrame: Up to Week 408 plus 30 days
measure: Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality
timeFrame: Up to Week 408 plus 30 days
measure: Percentage of Participants Experiencing Any Marked Treatment-Emergent Laboratory Abnormality
timeFrame: Up to Week 408 plus 30 days
measure: Hemoglobin at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
timeFrame: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
measure: Red Blood Cell (RBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
timeFrame: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
measure: White Blood Cell (WBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
timeFrame: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
measure: Platelet Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
timeFrame: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
measure: Alkaline Phosphatase at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
timeFrame: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
measure: Alanine Aminotransferase (ALT) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
timeFrame: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
measure: Aspartate Aminotransferase (AST) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
timeFrame: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
measure: HIV-1 RNA at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
timeFrame: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
measure: Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
timeFrame: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
measure: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
timeFrame: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
measure: CD4 Cell Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
timeFrame: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
measure: Incidence of Mortality
timeFrame: Up to Week 408 plus 30 days
Other outcomes:
Locations:
city: Pheonix
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Beverly Hills
country: United States
state: California
city: Costa Mesa
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: Palo Alto
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Francisco
country: United States
state: California
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: Manors
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: 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: West Springfield
country: United States
state: Massachusetts
city: St. Louis
country: United States
state: Michigan
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: Bronx
country: United States
state: New York
city: Manhasset
country: United States
state: New York
city: New York
country: United States
state: New York
city: Stonybrook
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Huntersville
country: United States
state: North Carolina
city: Hershey
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Memphis
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Annandale
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Tacoma
country: United States
state: Washington
city: Santurce
country: Puerto Rico
Study officials:
affiliation: Gilead Sciences
name: Martin Rhee, MD
role: STUDY_DIRECTOR
References: