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

This study has been completed.

First Received on May 13, 2002. Last Updated on June 23, 2005 History of Changes

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Tenofovir Tenofovir disoproxil Tenofovir Disoproxil Fumarate

U.S. FDA Resources

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

No publications provided

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

Keywords provided by Gilead Sciences:

treatment naive

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
Tenofovir

Tenofovir disoproxil
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on February 09, 2012