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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00016588
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:

May 17, 2001
August 31, 2001
June 24, 2005
May 2001
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No Changes Posted
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Tenofovir Disoproxil Fumarate (TDF) in HIV-1 Patients Who Have Never Taken Anti-HIV Drugs
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
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.
Patients receive TDF.
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Masking: None (Open Label)
Primary Purpose: Treatment
HIV Infections
Drug: Tenofovir disoproxil fumarate
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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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Gilead Sciences
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NIH AIDS Clinical Trials Information Service
May 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP