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

NCT00011089 | Unknown

• 2 other identifiers: 283GGS-00-955
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV Infections

Keywords

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

Interventions

Tenofovir disoproxil fumarate DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (1)

Medical Information

Foster City, California, 94404, United States

Location

MeSH Terms

Conditions

HIV Infections; Disease Progression

Interventions

Tenofovir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 9, 2001
• First Posted: August 31, 2001
• Study Start: February 1, 2001
• Last Updated: June 24, 2005

Record last verified: 2001-11

Locations

US (1)