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

March 23, 2016 updated by: Gilead Sciences

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
192

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percentage of Participants Experiencing Any Treatment-Emergent Study Dug-Related Adverse Event
Time Frame: Up to Week 408 plus 30 days
Up to Week 408 plus 30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
Time Frame: Up to Week 408 plus 30 days
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
Time Frame: Up to Week 408 plus 30 days
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
Time Frame: Up to Week 408 plus 30 days
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
Time Frame: Baseline; 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
Time Frame: Baseline; 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
Time Frame: Baseline; 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
Time Frame: Baseline; 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
Time Frame: Baseline; 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
Time Frame: Baseline; 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
Time Frame: Baseline; 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
Time Frame: Baseline; 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
Time Frame: Baseline; 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
Time Frame: Baseline; 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
Time Frame: Baseline; 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
Time Frame: Up to Week 408 plus 30 days
The percentage of participants who died was summarized.
Up to Week 408 plus 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gilead Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 8, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GS-US-183-0130

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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