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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
EVG
RTV
ARV regimen
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring 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

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EVG+RTV

Arm Description

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.

Outcomes

Primary Outcome Measures

Percentage of Participants Experiencing Any Treatment-Emergent Study Dug-Related Adverse Event

Secondary Outcome Measures

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.
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.
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.
Hemoglobin at Baseline and Change From Baseline at 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
White Blood Cell (WBC) Count at Baseline and Change From Baseline at 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
Alkaline Phosphatase at Baseline and Change From Baseline at 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
Aspartate Aminotransferase (AST) at Baseline and Change From Baseline at 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
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
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
CD4 Cell Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Incidence of Mortality
The percentage of participants who died was summarized.

Full Information

First Posted
February 28, 2007
Last Updated
March 23, 2016
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00445146
Brief Title
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

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
192 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EVG+RTV
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
EVG
Other Intervention Name(s)
Vitekta®, GS-9137
Intervention Description
Elvitegravir (EVG) tablet administered orally once daily with food
Intervention Type
Drug
Intervention Name(s)
RTV
Other Intervention Name(s)
Norvir®
Intervention Description
Ritonavir (RTV; /r) 100 mg capsule administered orally once daily with food
Intervention Type
Drug
Intervention Name(s)
ARV regimen
Intervention Description
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).
Primary Outcome Measure Information:
Title
Percentage of Participants Experiencing Any Treatment-Emergent Study Dug-Related Adverse Event
Time Frame
Up to Week 408 plus 30 days
Secondary Outcome Measure Information:
Title
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
Description
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.
Time Frame
Up to Week 408 plus 30 days
Title
Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality
Description
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.
Time Frame
Up to Week 408 plus 30 days
Title
Percentage of Participants Experiencing Any Marked Treatment-Emergent Laboratory Abnormality
Description
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.
Time Frame
Up to Week 408 plus 30 days
Title
Hemoglobin at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Time Frame
Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Title
Red Blood Cell (RBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Time Frame
Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Title
White Blood Cell (WBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Time Frame
Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Title
Platelet Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Time Frame
Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Title
Alkaline Phosphatase at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Time Frame
Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Title
Alanine Aminotransferase (ALT) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Time Frame
Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Title
Aspartate Aminotransferase (AST) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Time Frame
Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Title
HIV-1 RNA at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Time Frame
Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Title
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
Time Frame
Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Title
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
Time Frame
Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Title
CD4 Cell Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Time Frame
Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Title
Incidence of Mortality
Description
The percentage of participants who died was summarized.
Time Frame
Up to Week 408 plus 30 days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Rhee, MD
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
City
Pheonix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72207
Country
United States
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06851
Country
United States
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
City
Manors
State/Province
Florida
ZIP/Postal Code
33305
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33169
Country
United States
City
North Palm Beach
State/Province
Florida
ZIP/Postal Code
33408
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33602
Country
United States
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
City
West Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
City
St. Louis
State/Province
Michigan
ZIP/Postal Code
63108
Country
United States
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89074
Country
United States
City
Hillsborough
State/Province
New Jersey
ZIP/Postal Code
08844
Country
United States
City
Santa Fe
State/Province
New Mexico
ZIP/Postal Code
87505
Country
United States
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
City
Bronx
State/Province
New York
ZIP/Postal Code
11030
Country
United States
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
City
Stonybrook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27110
Country
United States
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75204
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Annandale
State/Province
Virginia
ZIP/Postal Code
22003
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
City
Santurce
ZIP/Postal Code
00921
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

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

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