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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

February 28, 2007
March 23, 2016
February 2007
March 2015   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00445146 on ClinicalTrials.gov Archive Site
  • 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.
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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.
Not Provided
Interventional
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • 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).
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.

Interventions:
  • Drug: EVG
  • Drug: RTV
  • Drug: ARV regimen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
192
March 2015
March 2015   (final data collection date for primary outcome measure)

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.
Both
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00445146
GS-US-183-0130
No
Not Provided
Not Provided
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Martin Rhee, MD Gilead Sciences
Gilead Sciences
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP