New York, New York 10021

  • HIV Infections


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.

Study summary:

Patients receive TDF.


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.



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Location Contact:

New York, New York 10021
United States

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Site Status: N/A

Data Source:

Date Processed: March 30, 2020

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