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
Information provided by:
First received: February 28, 2007
Last updated: March 15, 2011
Last verified: January 2007
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.
||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
| Study Start Date:
| Estimated Primary Completion Date:
||March 2013 (Final data collection date for primary outcome measure)
GS-9137 administered orally with ritonavir, once daily with food in combination with other antiretroviral agents
Other Name: elvitegravir
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00445146
||Martin Rhee, MD
No publications provided
||Martin Rhee, MD /Associate Director Clinical Research, Gilead Sciences, Inc
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 28, 2007
||March 15, 2011
||United States: Food and Drug Administration
Keywords provided by Gilead Sciences:
Highly Active Antiretroviral Activity
HIV, HIV-1, AIDS virus, Human Immunodeficiency Virus
Acquired Immune Deficiency Syndrome Virus
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on June 18, 2013
Acquired Immunodeficiency Syndrome
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action