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

This study has been completed.

Sponsor:

Information provided by:

Gilead Sciences

ClinicalTrials.gov Identifier:

NCT00036634

First received: May 13, 2002

Last updated: June 23, 2005

Last verified: November 2004

History of Changes

Tracking Information
First Received Date ^ICMJE	May 13, 2002
Last Updated Date	June 23, 2005
Start Date ^ICMJE	March 2002
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00036634 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Dose Escalation Study of GS-7340-02 in Treatment Naive Patients
Official Title ^ICMJE	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
Brief Summary	This study will look at two doses of GS-7340-02 versus tenofovir DF.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1 Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: GS-7340-02
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	30
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00036634
Other Study ID Numbers ^ICMJE	GS-120-1101
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Gilead Sciences
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Gilead Sciences
Verification Date	November 2004
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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