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

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

This study has been completed.

Study NCT00036634. Last updated on June 23, 2005. Information provided by Gilead Sciences

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	A Dose Escalation Study of GS-7340-02 in Treatment Naive Patients
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
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 ^†	Interventional
Study Design ^†	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	HIV Infections
Intervention ^†	Drug: GS-7340-02
MEDLINE PMIDs
Links

Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†	30
Start Date ^†	March 2002
Completion Date
Eligibility 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
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00036634
Organization ID	GS-120-1101
Secondary IDs ^††
Study Sponsor ^†	Gilead Sciences
Collaborators ^††
Investigators ^†
Information Provided By	Gilead Sciences
Verification Date	November 2004
First Received Date ^†	May 13, 2002
Last Updated Date	June 23, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.