Tenofovir Disoproxil Fumarate (TDF) in HIV-1 Patients Who Have Never Taken Anti-HIV Drugs

HIV Infections Clinical Trial

Official title:

An Open-Label Study to Assess the Anti-HIV-1 Activity of Tenofovir Disoproxil Fumarate (TDF) in Antiretroviral-Naive Patients Who Are Chronically Infected With HIV-1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00016588
• Other study ID #: 283H
• Secondary ID: GS-00-917
• Status: Completed
• Phase: N/A
• First received: May 17, 2001
• Last updated: June 23, 2005
• Start date: May 2001

Study information

• Verified date: May 2002
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to look at the effectiveness of tenofovir disoproxil fumarate (TDF) in HIV-infected patients who have never taken anti-HIV drugs.

Description:

Patients receive TDF.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria

Patients may be eligible for this study if they:

• Are HIV-positive.

• Have a plasma viral load (level of HIV in the blood) of 10,000 copies/ml or more.

• Have a CD4 count of 50 cells/mm3 or more.

• Have a negative pregnancy test.

• Agree to use 2 forms of barrier birth control while on the study and for 30 days afterwards.

• Are 18 to 65 years old.

Exclusion Criteria

Patients will not be eligible for this study if they:

• Have had treatment with any of the following types of anti-HIV drugs: nucleoside reverse transcriptase inhibitors, nucleotide reverse transcriptase inhibitors (e.g., adefovir dipivoxil or TDF), protease inhibitors, or nonnucleoside reverse transcriptase inhibitors.

• Have received a vaccination within 30 days before study entry.

• Have had a new AIDS-defining illness diagnosed within 30 days before study entry.

• Are taking any of the following: drugs that may cause kidney problems, including aminoglycoside antibiotics, cidofovir, cisplatin, foscarnet, intravenous (IV) amphotericin B, IV vancomycin, oral and IV ganciclovir, and valganciclovir; probenecid; chemotherapy; steroid drugs; interleukin-2; or investigational drugs.

• Are pregnant or breast-feeding.

• Have difficulty taking, absorbing, or tolerating drugs by mouth, as may be shown by long-term nausea or vomiting.

• Abuse alcohol or drugs.

• Have cancer other than Kaposi's sarcoma or basal cell carcinoma.

• Have other infections that need injectable antibiotics within 15 days before study entry.

• Have had kidney or bone disease.

• Have any medical conditions or past treatments that the study investigator believes would make the patient unsuitable for the study.

Study Design

Endpoint Classification: Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Tenofovir disoproxil fumarate

Locations

Country	Name	City	State
United States	Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

References & Publications (1)

Louie M, Hogan C, Hurley A, Captan B, Flaherty J, Lamy P, Balagtas A, Coakley D, Chung C, Ho D. Determining The Relative Efficacy of Tenofovir DF Using Frequent Measurments of HIV-1 RNA During A Short Course of Monotherapy In Antiretroviral Drug Naive Individuals. D, Markowitz M. 9th Conference on Retroviruses and Opportunistic Infections 2002 Feb 24-28