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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
This study is ongoing, but not recruiting participants.
Sponsored by: Gilead Sciences
Information provided by: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00445146
  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 II

MedlinePlus related topics: AIDS
Drug Information available for: Ritonavir GS 9137
U.S. FDA Resources
Study Type: Observational
Study Design: Longitudinal, Defined Population, Prospective Study
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

Further study details as provided by Gilead Sciences:

Study Start Date: March 2007
  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
Sponsors and Collaborators
Gilead Sciences
  More Information

Study ID Numbers: GS-US-183-0130
Study First Received: February 28, 2007
Last Updated: April 2, 2007
ClinicalTrials.gov Identifier: NCT00445146  
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

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
Ritonavir
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 16, 2009