NCT00036634

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 hiv-infections

Timeline
Completed

Started Mar 2002

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 14, 2002

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2003

Completed
Last Updated

January 15, 2014

Status Verified

January 1, 2014

Enrollment Period

11 months

First QC Date

May 13, 2002

Last Update Submit

January 13, 2014

Conditions

HIV Infections

Keywords

treatment naive

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Change from baseline in HIV-1 RNA (log10 copies/mL)

    Baseline to Week 2

  • Change from baseline in CD4 cell count (cells/mm3)

    Baseline to Week 2

Study Arms (3)

Tenofovir DF

ACTIVE COMPARATOR

Participants received tenofovir DF 300 mg for 14 days

Drug: Tenofovir DF

Tenofovir alafenamide 50 mg

EXPERIMENTAL

Participants received tenofovir alafenamide 50 mg for 14 days

Drug: Tenofovir alafenamide

Tenofovir alafenamide 150 mg

EXPERIMENTAL

Participants received tenofovir alafenamide 150 mg for 14 days

Drug: Tenofovir alafenamide

Interventions

Tenofovir DFDRUG

Tenofovir DF tablet administered orally once daily

Also known as: Viread®
Tenofovir DF
Tenofovir alafenamideDRUG

Tenofovir alafenamide tablet(s) administered orally once daily

Also known as: GS-7340
Tenofovir alafenamide 150 mgTenofovir alafenamide 50 mg

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Stanford Positive Care Program

Palo Alto, California, 94304, United States

Location

Protocare Trials Chicago Center for Clinical Trials

Chicago, Illinois, 60610, United States

Location

Rockefeller University Hospital

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Tenofovirtenofovir alafenamide

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2002

First Posted

May 14, 2002

Study Start

March 1, 2002

Primary Completion

February 1, 2003

Study Completion

February 1, 2003

Last Updated

January 15, 2014

Record last verified: 2014-01

Locations

US(3)