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
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Elvitegravir
Drug: Ritonavir
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:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 122
Study Start Date: March 2007
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Elvitegravir/r
Participants will bee assessed during study visits once every 8 weeks until Week 48 and then once every 12 weeks thereafter.
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).

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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

No publications provided

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
Last Updated: April 25, 2014
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:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Ritonavir
Anti-Retroviral Agents
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014