A Dose Escalation Study of Tenofovir Alafenamide in Treatment-Naive Patients

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00036634
• Other study ID #: GS-120-1101
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 13, 2002
• Last updated: January 13, 2014
• Start date: March 2002
• Est. completion date: February 2003

Study information

• Verified date: January 2014
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study evaluated two doses of tenofovir alafenamide versus tenofovir disoproxil fumarate (tenofovir DF).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2003
• Est. primary completion date: February 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Tenofovir DF
Tenofovir DF tablet administered orally once daily
• Tenofovir alafenamide
Tenofovir alafenamide tablet(s) administered orally once daily

Locations

Country	Name	City	State
United States	Protocare Trials Chicago Center for Clinical Trials	Chicago	Illinois
United States	Rockefeller University Hospital	New York	New York
United States	Stanford Positive Care Program	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time-weighted average change from baseline through Week 2 (DAVG2) for HIV-1 RNA (log10 copies/mL)	DAVG2 was defined as the time-weighted average between baseline value through the last available value up to week 2 minus the baseline value.	Baseline to Week 2	No
Secondary	Change from baseline in HIV-1 RNA (log10 copies/mL)		Baseline to Week 2	No
Secondary	Change from baseline in CD4 cell count (cells/mm3)		Baseline to Week 2	No