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

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tenofovir disoproxil fumarate
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV-1, Adenine, Anti-HIV Agents, Viral Load, Organophosphorus Compounds

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 17, 2001
Last Updated
June 23, 2005
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00016588
Brief Title
Tenofovir Disoproxil Fumarate (TDF) in HIV-1 Patients Who Have Never Taken Anti-HIV Drugs
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2002
Overall Recruitment Status
Completed
Study Start Date
May 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Gilead Sciences

4. Oversight

5. Study Description

Brief Summary
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
Patients receive TDF.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV-1, Adenine, Anti-HIV Agents, Viral Load, Organophosphorus Compounds

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tenofovir disoproxil fumarate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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
Results Reference
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Tenofovir Disoproxil Fumarate (TDF) in HIV-1 Patients Who Have Never Taken Anti-HIV Drugs

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