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

Tracking Information
First Received Date ^ICMJE	May 13, 2002
Last Updated Date	June 23, 2005
Start Date ^ICMJE	March 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00036634 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

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
Study Phase	Phase I, Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: GS-7340-02
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	30
Completion Date
Primary Completion Date
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 ID ^ICMJE	NCT00036634
Responsible Party
Study ID Numbers ^ICMJE	GS-120-1101
Study Sponsor ^ICMJE	Gilead Sciences
Collaborators ^ICMJE
Investigators ^ICMJE
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