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



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

For Condition: HIV Infections
Status: Recruiting
Sponsor(s): Gilead Sciences ,
Synopsis: This study will look at two doses of GS-7340-02 versus tenofovir DF.
Details:
Eligibility:
Study Type:  Interventional, Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 30

Location and Contact Information:

Rockefeller University Hospital *Recruiting*
New York City,  New York,  10021
United States
Recruiting Arlene  Hurley 212-327-7281

Stanford Positive Care Program *Recruiting*
Palo Alto,  California,  94304
United States
Recruiting Kim  Vu 650-498-5306

Protocare Trials Chicago Center for Clinical Trials *Recruiting*
Chicago,  Illinois,  60610
United States
Recruiting Debbie  Carpenter 312-494-2317


Additional Information:
Study ID Numbers:  GS-120-1101; 
Study Start Date: March 2002
Record last reviewed: May 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00036634

Other Hiv Infections Studies:
1. Safety of and Immune Response to a New HIV Vaccine: HIV CTL MEP

2. The Safety and Effectiveness of Adefovir Dipivoxil Plus Indinavir Combined with Zidovudine or Lamivudine or Stavudine in HIV-Infected Patients Who Have Not Taken Anti-HIV Drugs

3. A Study to determine how and why HIV-Infected subjects on anti-viral treatment develop Lipodystrophy

4. The Safety and Effectiveness of Isoprinosine in Patients with Weakened Immune Systems and Lymph Node Disease

5. A Phase I/II Clinical Study of Nystatin I.V. (Intravenous) in Patients With HIV Infection.

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