CClinicalTrials.gg
Status unknownNCT00011089Updated Jun 24, 2005

Tenofovir Disoproxil Fumarate in HIV-Infected Patients Who Have Not Had Success With Other Anti-HIV Drug Combinations

An interventional study of Tenofovir disoproxil fumarate in HIV Infections, sponsored by Gilead Sciences. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by Gilead Sciences · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2001), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to make tenofovir disoproxil fumarate (DF) available to HIV-infected patients who have failed other anti-HIV drug combinations, who have few treatment choices available, and whose disease may get worse. This study will allow patients to obtain tenofovir DF before it is approved for marketing.

Read the detailed description

Patients receive daily doses of tenofovir DF.

02

Conditions studied

  • HIV Infections

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Keywords

  • HIV-1
  • Disease Progression
  • Reverse Transcriptase Inhibitors
  • Anti-HIV Agents
  • 9-(2-phosphonylmethoxypropyl)adenine
03

In context

HIV Infections

4,259 studies on the registry are indexed under HIV Infections; 241 are open to participants now.

Browse HIV Infections studies →

Lead sponsor

Gilead Sciences is the lead sponsor of 680 studies on the registry; 24 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 249 (96%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Patients may be eligible for this study if they:

  • Are HIV-positive.
  • Have a viral load (level of HIV in the blood) of at least 10,000 copies/ml by PCR within the previous 2 months.
  • Have a CD4 count of 100 cells/mm3 or lower within the previous 2 months. Patients with a CD4 count above 100 and as high as 200 cells/mm3 may also be eligible if they had an opportunistic (AIDS-related) infection within the past 90 days.
  • Have failed treatment with at least 2 protease inhibitors (PIs) or at least 1 PI plus a nonnucleoside reverse transcriptase inhibitor (NNRTI).
  • Are not able to get effective treatment with a combination of currently approved anti-HIV drugs.
  • Are at least 18 years old.
  • Have a negative serum pregnancy test.
  • Are willing to use a barrier method of birth control (both males and females) while on the study and for 30 days after taking the drug.

Exclusion criteria

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Have or have had kidney disease or bone disease.
  • Are pregnant or breast-feeding.
  • Abuse alcohol or drugs.
  • Are taking, or have taken within 7 days of enrolling in the study, adefovir dipivoxil or drugs that may cause kidney problems, including aminoglycoside antibiotics, cidofovir, foscarnet, intravenous (IV) amphotericin B, IV pentamidine, IV vancomycin, and chemotherapy (e.g., cisplatin).
  • Have any medical conditions or have had any medications that the study investigator believes will make him/her unsuitable for the study.
05

Study design

Phase
Not applicable
Primary purpose
Treatment

Interventions

  • DrugTenofovir disoproxil fumarate
06

Study locations

1 site
  • Medical Information
    Foster City, California 94404, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00011089
Lead sponsor
Gilead Sciences
First posted
Aug 31, 2001
Start date
Feb 2001
Last update
Jun 24, 2005
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2001. You cannot join it, but the record below documents what was studied.

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