Safety of EVG+RTV Administered With Other Antiretroviral Agents for the Treatment of HIV-1 Infection

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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: EVG; Drug: RTV; Drug: ARV regimen

• Study Type: Interventional
• Enrollment (Actual): 192
• Phase: Phase 2

Contacts and Locations

Study Locations

• Puerto Rico
  • Santurce, Puerto Rico, 00921
• United States
  • Arizona
    • Pheonix, Arizona, United States, 85006
  • Arkansas
    • Little Rock, Arkansas, United States, 72207
  • California
    • Beverly Hills, California, United States, 90211
    • Costa Mesa, California, United States, 92626
    • Fountain Valley, California, United States, 92708
    • Long Beach, California, United States, 90813
    • Los Angeles, California, United States, 90033
    • Newport Beach, California, United States, 92663
    • Palo Alto, California, United States, 94305
    • San Diego, California, United States, 92103
    • San Francisco, California, United States, 94110
  • Connecticut
    • Norwalk, Connecticut, United States, 06851
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
  • Florida
    • Atlantis, Florida, United States, 33462
    • Fort Lauderdale, Florida, United States, 33308
    • Manors, Florida, United States, 33305
    • Miami, Florida, United States, 33136
    • North Miami Beach, Florida, United States, 33169
    • North Palm Beach, Florida, United States, 33408
    • Orlando, Florida, United States, 32803
    • Sarasota, Florida, United States, 34239
    • Tampa, Florida, United States, 33602
  • Georgia
    • Decatur, Georgia, United States, 30033
    • Macon, Georgia, United States, 31201
  • Illinois
    • Chicago, Illinois, United States, 60657
  • Maryland
    • Baltimore, Maryland, United States, 21205
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
    • West Springfield, Massachusetts, United States, 01107
  • Michigan
    • St. Louis, Michigan, United States, 63108
  • Nevada
    • Henderson, Nevada, United States, 89074
  • New Jersey
    • Hillsborough, New Jersey, United States, 08844
  • New Mexico
    • Santa Fe, New Mexico, United States, 87505
  • New York
    • Albany, New York, United States, 12208
    • Bronx, New York, United States, 11030
    • Manhasset, New York, United States, 11030
    • New York, New York, United States, 10016
    • Stonybrook, New York, United States, 11794
  • North Carolina
    • Durham, North Carolina, United States, 27110
    • Huntersville, North Carolina, United States, 28078
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
    • Philadelphia, Pennsylvania, United States, 19107
  • Tennessee
    • Memphis, Tennessee, United States, 38105
  • Texas
    • Dallas, Texas, United States, 75204
    • Houston, Texas, United States, 77030
  • Virginia
    • Annandale, Virginia, United States, 22003
  • Washington
    • Seattle, Washington, United States, 98101
    • Tacoma, Washington, United States, 98405

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: EVG+RTV; EVG 85 mg or 150 mg + RTV + ARV regimen Participants receiving lopinavir/ritonavir (LPV/r) or atazanavir/ritonavir (ATV/r) as part of their ARV regimen will receive EVG 85 mg and all other participants will receive EVG 150 mg. Some participants may receive EVG 300 mg during the course of protocol amendment 2.

Drug: EVG; Elvitegravir (EVG) tablet administered orally once daily with food; Other Names: Vitekta®; GS-9137; Drug: RTV; Ritonavir (RTV; /r) 100 mg capsule administered orally once daily with food; Other Names: Norvir®; Drug: ARV regimen; The components of the ARV regimen will be selected by the investigator without input from the sponsor. The antiretroviral regimen must consist of at least 2 agents, not including the non-nucleoside reverse transcriptase inhibitors (NNRTIs) efavirenz, nevirapine, or delavirdine; the protease inhibitors saquinavir, nelfinavir, or indinavir; or investigational agents (without sponsor approval).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants Experiencing Any Treatment-Emergent Study Dug-Related Adverse Event	Up to Week 408 plus 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Experiencing Treatment-Emergent Adverse Events	Adverse events (AEs) occurring during treatment and for 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event.	Up to Week 408 plus 30 days
Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality	Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant.	Up to Week 408 plus 30 days
Percentage of Participants Experiencing Any Marked Treatment-Emergent Laboratory Abnormality	A 'marked abnormality' was defined as a shift from grade 0 (or missing) at baseline to at least grade 3 postbaseline; or grade 1 at baseline to grade 4 postbaseline.	Up to Week 408 plus 30 days
Hemoglobin at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384		Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Red Blood Cell (RBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384		Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
White Blood Cell (WBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384		Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Platelet Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384		Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Alkaline Phosphatase at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384		Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Alanine Aminotransferase (ALT) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384		Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Aspartate Aminotransferase (AST) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384		Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
HIV-1 RNA at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384		Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
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		Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
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		Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
CD4 Cell Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384		Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Incidence of Mortality	The percentage of participants who died was summarized.	Up to Week 408 plus 30 days

Collaborators and Investigators

• Sponsor: Gilead Sciences

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: February 28, 2007
• First Submitted That Met QC Criteria: March 7, 2007
• First Posted (Estimate): March 8, 2007

Study Record Updates

• Last Update Posted (Estimate): April 25, 2016
• Last Update Submitted That Met QC Criteria: March 23, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Open-label; treatment experienced; Phase 2; HAART; Antiretroviral Agents; Acquired Immune Deficiency Syndrome Virus; Rollover; Integrase Inhibitor; Highly Active Antiretroviral Activity; HIV, HIV-1, AIDS virus, Human Immunodeficiency Virus
• Additional Relevant MeSH Terms: Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Integrase Inhibitors; Elvitegravir
• Other Study ID Numbers: GS-US-183-0130