Trial record 5 of 24 for:
" February 28, 2007":" March 30, 2007"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]
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
Recruitment status was Active, not recruiting
Sponsor:
Gilead Sciences
Information provided by:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00445146
First received: February 28, 2007
Last updated: March 15, 2011
Last verified: January 2007
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: GS-9137 |
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:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Ritonavir
U.S. FDA Resources
Further study details as provided by Gilead Sciences:
Primary Outcome Measures:
- Adverse Events [ Designated as safety issue: Yes ]The incidence of study drug related, treatment emergent adverse events
| Enrollment: | 122 |
| Study Start Date: | March 2007 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: GS-9137 |
Drug: GS-9137
GS-9137 administered orally with ritonavir, once daily with food in combination with other antiretroviral agents
Other Name: elvitegravir
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00445146
Show 41 Study Locations
Show 41 Study LocationsSponsors and Collaborators
Gilead Sciences
Investigators
| Study Director: | Martin Rhee, MD | Gilead Sciences |
More Information
No publications provided
| Responsible Party: | Martin Rhee, MD /Associate Director Clinical Research, Gilead Sciences, Inc |
| ClinicalTrials.gov Identifier: | NCT00445146 History of Changes |
| Other Study ID Numbers: | GS-US-183-0130 |
| Study First Received: | February 28, 2007 |
| Last Updated: | March 15, 2011 |
| 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 Integrase Inhibitors 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 June 18, 2013