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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00445146
First received: February 28, 2007
Last updated: March 23, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention Phase
HIV Infections
Drug: EVG
Drug: RTV
Drug: ARV regimen
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Percentage of Participants Experiencing Any Treatment-Emergent Study Dug-Related Adverse Event [ Time Frame: Up to Week 408 plus 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of Participants Experiencing Treatment-Emergent Adverse Events [ Time Frame: Up to Week 408 plus 30 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to Week 408 plus 30 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to Week 408 plus 30 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Incidence of Mortality [ Time Frame: Up to Week 408 plus 30 days ] [ Designated as safety issue: No ]
    The percentage of participants who died was summarized.


Enrollment: 192
Study Start Date: February 2007
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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).

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00445146

  Show 48 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Martin Rhee, MD Gilead Sciences
  More Information

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00445146     History of Changes
Other Study ID Numbers: GS-US-183-0130 
Study First Received: February 28, 2007
Results First Received: March 23, 2016
Last Updated: March 23, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
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

Additional relevant MeSH terms:
Infection
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Ritonavir
Anti-Retroviral Agents
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors

ClinicalTrials.gov processed this record on December 07, 2016