NCT00002453

Brief Summary

This study allows patients who need a new anti-HIV treatment to take tenofovir disoproxil fumarate (tenofovir DF), an experimental drug. This study also looks at any side effects the drug causes.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P50-P75 for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

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

December 1, 1999

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2000

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

May 1, 2000

First QC Date

January 24, 2000

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

HIV-1Drug Therapy, CombinationDisease ProgressionAnti-HIV Agents

Interventions

Tenofovir disoproxil fumarateDRUG

Eligibility Criteria

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

You may qualify if:

  • You may be eligible for this study if you:
  • Are HIV-positive.
  • Have a viral load greater than or equal to 10,000 copies/ml.
  • Have a CD4 count less than or equal to 50 cells/mm3, or have a CD4 count greater than 50 and no more than 200 cells/mm3 with an opportunistic (AIDS-related) infection within 90 days of study entry. (Patients with a CD4 count above 200 cells/mm3 may be considered depending on drug supply.)
  • Are at least 18 years old.
  • Agree to use barrier methods of birth control (such as condoms) while on the study and for 30 days afterward.
  • Have a life expectancy of at least one year.

You may not qualify if:

  • You will not be eligible for this study if you:
  • Have a history of a serious kidney or bone disease.
  • Have severe nausea, vomiting, or trouble taking medications by mouth.
  • Are pregnant or breast-feeding.
  • Abuse alcohol or other substances that your doctor thinks would interfere with taking this medicine.
  • Are taking any medicines that interfere with kidney functions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tenofovir Coordinating Center

Foster City, California, 94404, United States

Location

MeSH Terms

Conditions

HIV InfectionsDisease Progression

Interventions

Tenofovir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 24, 2000

First Posted

August 31, 2001

Study Start

December 1, 1999

Last Updated

June 24, 2005

Record last verified: 2000-05

Locations

US(1)