A Phase 2 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 recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by Gilead Sciences.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00445146
First received: February 28, 2007
Last updated: March 15, 2011
Last verified: January 2007

February 28, 2007
March 15, 2011
March 2007
March 2013   (final data collection date for primary outcome measure)
Adverse Events [ Designated as safety issue: Yes ]
The incidence of study drug related, treatment emergent adverse events
Not Provided
Complete list of historical versions of study NCT00445146 on ClinicalTrials.gov Archive Site
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A Phase 2 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
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 GS-9137/r for those subjects currently benefiting from their participation in an ongoing GS-9137/r study. This study will also provide initial access to GS-9137/r for those subjects who have completed a GS-9137/r study in which the subject was participating in a treatment arm that did not include GS-9137/r. This study will continue to monitor the safety and tolerability of GS-9137/r through periodic assessment of adverse events, changes in concomitant medications and clinical laboratory tests. This study is an open-label study.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
Drug: GS-9137
GS-9137 administered orally with ritonavir, once daily with food in combination with other antiretroviral agents
Other Name: elvitegravir
Experimental: GS-9137
Intervention: Drug: GS-9137
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
Not Provided
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Completion of a prior GS-9137/r treatment study without treatment-limiting toxicity.
  • Males and females (of childbearing potential i.e., 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
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No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00445146
GS-US-183-0130
No
Martin Rhee, MD /Associate Director Clinical Research, Gilead Sciences, Inc
Gilead Sciences
Not Provided
Study Director: Martin Rhee, MD Gilead Sciences
Gilead Sciences
January 2007

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