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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00016588
First received: May 17, 2001
Last updated: June 23, 2005
Last verified: May 2002
  Purpose

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.


Condition Intervention
HIV Infections
Drug: Tenofovir disoproxil fumarate

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Study Start Date: May 2001
Detailed Description:

Patients receive TDF.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00016588

Locations
United States, New York
Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ
New York, New York, United States, 10021
Sponsors and Collaborators
Gilead Sciences
  More Information

Publications:
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

ClinicalTrials.gov Identifier: NCT00016588     History of Changes
Other Study ID Numbers: 283H, GS-00-917
Study First Received: May 17, 2001
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
HIV-1
Adenine
Anti-HIV Agents
Viral Load
Organophosphorus Compounds

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Anti-HIV Agents
Tenofovir
Tenofovir disoproxil
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014