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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2001-05-31

Brief Summary

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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.

Detailed Description

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Patients receive TDF.

Conditions

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HIV Infections

Keywords

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HIV-1 Adenine Anti-HIV Agents Viral Load Organophosphorus Compounds

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Tenofovir disoproxil fumarate

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ

New York, New York, United States

Site Status

Countries

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United States

References

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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

Reference Type BACKGROUND

Other Identifiers

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GS-00-917

Identifier Type: -

Identifier Source: secondary_id

283H