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


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Ketotifen Fumarate Ophthalmic

ketotifen fumarate; Zaditor


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

This study has been completed.

Sponsored by: Gilead Sciences
Information provided by: AIDS Clinical Trials Information Service

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 Treatment or Intervention
HIV Infections
 Drug: Tenofovir disoproxil fumarate

MedlinePlus related topics:  AIDS

Study Type: Interventional
Study Design: Treatment, Open Label, Efficacy Study

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

Further Study Details: 

Study start: May 2001

Patients receive TDF.

Eligibility

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

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.

Location Information


New York
      Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ, New York,  New York,  10021,  United States

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

Study ID Numbers:  283H; GS-00-917
Record last reviewed:  May 2002
Last Updated:  October 13, 2004
Record first received:  May 17, 2001
ClinicalTrials.gov Identifier:  NCT00016588
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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October 7, 2008



Page Updated: September 6, 2005
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