Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Phase 2 Study of the Safety of Ritonavir-Boosted Elvitegravir Administered in Combination With Other Antiretroviral Agents for the Treatment of HIV-1 Infected Subjects

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00445146
First received: February 28, 2007
Last updated: April 25, 2014
Last verified: April 2014

February 28, 2007
April 25, 2014
March 2007
October 2014   (final data collection date for primary outcome measure)
Incidence of study drug-related, treatment-emergent adverse events. [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
The percentage of participants experiencing study drug-related, treatment-emergent adverse events will be summarized.
Not Provided
Complete list of historical versions of study NCT00445146 on ClinicalTrials.gov Archive Site
  • Incidence of treatment-emergent adverse events [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
    The percentage of participants experiencing treatment-emergent adverse events will be summarized.
  • Incidence of treatment-emergent Grade 3 and 4 adverse events [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
    The percentage of participants experiencing treatment-emergent Grade 3 and 4 adverse events will be summarized.
  • Incidence of study drug-related, treatment-emergent Grade 3 and 4 adverse events [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
    The percentage of participants experiencing study drug-related, treatment-emergent Grade 3 and 4 adverse events will be summarized.
  • Incidence of treatment-emergent laboratory toxicity [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
    Incidence of treatment-emergent laboratory abnormalities, defined as values that increase at least one toxicity grade from baseline at any time post baseline up to and including the date of last dose of study drug plus 30 days, will be summarized. Graded laboratory abnormalities will be defined using the GSI Grading Scale for Severity of Adverse Events and Laboratory Abnormalities.
  • Incidence of marked treatment-emergent laboratory toxicity [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
    Incidence of marked treatment-emergent laboratory abnormalities, defined as a shift from a baseline Grade 0 to a post-baseline Grade 3 or Grade 4 or from a baseline Grade 1 to a post-baseline Grade 4, will be summarized. Graded laboratory abnormalities will be defined using the GSI Grading Scale for Severity of Adverse Events and Laboratory Abnormalities.
  • Incidence of serious adverse events [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
    The percentage of participants experiencing study serious adverse events will be summarized.
  • Change from baseline in chemistry and hematology parameters [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
    Chemistry and hematology data (using conventional units) will be summarized by the observed data and by the change from baseline. Graded laboratory abnormalities will be defined using the GSI Grading Scale for Severity of Adverse Events and Laboratory Abnormalities.
  • Change from baseline in log10 HIV-1 RNA [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
  • Proportion of participants achieving HIV-1 RNA < 400 copies/mL [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
  • Proportion of participants achieving HIV-1 RNA < 50 copies/mL [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
  • Change from baseline in CD4 cell count [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
  • Incidence of mortality [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
    The incidence of mortality will be summarized.
Not Provided
Not Provided
Not Provided
 
A Phase 2 Study of the Safety of Ritonavir-Boosted Elvitegravir Administered in Combination With Other Antiretroviral Agents for the Treatment of HIV-1 Infected Subjects
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

This study is being initiated to provide continued access to ritonavir-boosted elvitegravir (EVG/r; GS-9137/r) for those participants currently benefiting from their participation in an ongoing EVG/r study. This study will also provide initial access to EVG/r for those participants who have completed a EVG/r study in which the participant was participating in a treatment arm that did not include EVG/r.

While on study, participants will be monitored for safety using periodic assessments of concomitant medications, adverse events and laboratory tests. Participants will be seen once every 8 weeks for the first 48 weeks of the study. Upon completion of 48 weeks, study visits will occur once every 12 weeks until EVG becomes commercially available, or until Gilead elects to terminate the study.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: Elvitegravir
    Elvitegravir 150 mg tablet administered orally once daily with food
    Other Name: GS-9137
  • Drug: Ritonavir
    Ritonavir (RTV; /r) 100 mg capsule administered orally once daily with food
    Other Name: Norvir®
  • Drug: ARV regimen
    The components of the antiretroviral (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: Elvitegravir/r
Participants will bee assessed during study visits once every 8 weeks until Week 48 and then once every 12 weeks thereafter.
Interventions:
  • Drug: Elvitegravir
  • Drug: Ritonavir
  • 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.
 
Active, not recruiting
122
October 2014
October 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Completion of a prior EVG/r treatment study without treatment-limiting toxicity.
  • Males and females (of childbearing potential ie, not surgically sterile or at least two years post-menopausal) must agree to utilize effective contraception methods (two separate forms of contraception, one of which must be an effective barrier method, or be non-heterosexually active, practice sexual abstinence, or have a vasectomized partner(confirmed sterile)) while on study treatment and for 30 days following the last dose of study drug.
  • The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.

Exclusion Criteria:

  • Females who are pregnant or breastfeeding.
  • Participation in any other clinical trial without prior approval from the Sponsor is prohibited while participating in this trial.
  • Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements.
  • Subjects receiving ongoing therapy with contra indicated drugs.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00445146
GS-US-183-0130
No
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Martin Rhee, MD Gilead Sciences
Gilead Sciences
April 2014

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