Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Gilead Sciences


Information provided by (Responsible Party)
Gilead Sciences
ClinicalTrials.gov Identifier
NCT00036634

First received: May 13, 2002
Last updated: January 13, 2014
Last Verified: January 2014
History of Changes
Purpose

Purpose

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

Condition Intervention Phase
HIV Infections

Drug : Tenofovir DF
Drug : Tenofovir alafenamide
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Further study details as provided by Gilead Sciences:

Primary Outcome Measures

  • Time-weighted average change from baseline through Week 2 (DAVG2) for HIV-1 RNA (log10 copies/mL) [ Time Frame: Baseline to Week 2 ]
    DAVG2 was defined as the time-weighted average between baseline value through the last available value up to week 2 minus the baseline value.
Secondary Outcome Measures:
  • Change from baseline in HIV-1 RNA (log10 copies/mL) [ Time Frame: Baseline to Week 2 ]
  • Change from baseline in CD4 cell count (cells/mm3) [ Time Frame: Baseline to Week 2 ]

Enrollment: 30
Study Start Date: March 2002
Study Completion Date: February 2003
Primary Completion Date: February 2003 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Active Comparator: Tenofovir DF
Participants received tenofovir DF 300 mg for 14 days
Drug: Tenofovir DF

Tenofovir DF tablet administered orally once daily

Other Name: Viread®
Experimental: Tenofovir alafenamide 50 mg
Participants received tenofovir alafenamide 50 mg for 14 days
Drug: Tenofovir alafenamide

Tenofovir alafenamide tablet(s) administered orally once daily

Other Name: GS-7340
Experimental: Tenofovir alafenamide 150 mg
Participants received tenofovir alafenamide 150 mg for 14 days
Drug: Tenofovir alafenamide

Tenofovir alafenamide tablet(s) administered orally once daily

Other Name: GS-7340
Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 65 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00036634

Locations

United States, California
Stanford Positive Care Program
Palo Alto, California, United States, 94304
United States, Illinois
Protocare Trials Chicago Center for Clinical Trials
Chicago, Illinois, United States, 60610
United States, New York
Rockefeller University Hospital
New York, New York, United States, 10021

Sponsors and Collaborators

Gilead Sciences
More Information

More Information


Responsible Party: Gilead Sciences  
ClinicalTrials.gov Identifier: NCT00036634   History of Changes  
Other Study ID Numbers: GS-120-1101  
Study First Received: May 13, 2002  
Last Updated: January 13, 2014  

Keywords provided by Gilead Sciences:

treatment naive

Additional relevant MeSH terms:
HIV Infections
Tenofovir

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.