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A Dose Escalation Study of GS-7340-02 in Treatment Naive Patients

This study has been completed.

Sponsored by: Gilead Sciences
Information provided by: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00036634
  Purpose

This study will look at two doses of GS-7340-02 versus tenofovir DF.


Condition Intervention Phase
HIV Infections
 Drug: GS-7340-02
 Phase I
Phase II

MedlinePlus related topics:   AIDS   

ChemIDplus related topics:   Tenofovir    Tenofovir disoproxil    Tenofovir Disoproxil Fumarate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   A Phase 1/2, Randomized, Double-Blind, Active Controlled, Dose Escalation Study of the Safety, Tolerance, Pharmacokinetic,, and Antiviral Activity of GS-7340-02 in Antiretroviral-Naive Patients Who Are Chronically Infected With HIV-1

Further study details as provided by Gilead Sciences:

Estimated Enrollment:   30
Study Start Date:   March 2002

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria

  • HIV-1 RNA levels greater than or equal to 30,000 copies/mL
  • CD4 count greater than or equal to 200 cells/mm3
  • Serum creatinine <1.5 mg/dl
  • Hepatic transaminases less than or equal to 2.5 times the upper limit of normal
  • Total bilirubin less than or equal to 1.5 mg/dL
  • Adequate hematologic function
  • Serum amylase less than or equal to 1.5 times the upper limit of normal
  • Serum phosphate greater than or equal to 2.2 mg/dL
  • Not pregnant

Exclusion Criteria

  • Prior treatment with antiretroviral therapy
  • Immunization within 30 days of study entry
  • A new AIDS defining condition within 30 days of study entry
  • Receiving nephrotoxic agents, probenecid, chemotherapeutic agents, corticosteroids, interleukin-2
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00036634

Locations
United States, California
Stanford Positive Care Program    
      Palo Alto, California, United States, 94304
United States, Illinois
Protocare Trials Chicago Center for Clinical Trials    
      Chicago, Illinois, United States, 60610
United States, New York
Rockefeller University Hospital    
      New York, New York, United States, 10021

Sponsors and Collaborators
Gilead Sciences
  More Information


Study ID Numbers:   GS-120-1101
First Received:   May 13, 2002
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00036634
Health Authority:   United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
treatment naive  

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

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

ClinicalTrials.gov processed this record on October 10, 2008

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