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
2 other identifiers
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
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1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2001
CompletedFirst Submitted
Initial submission to the registry
May 17, 2001
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
May 1, 2002
May 17, 2001
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (1)
Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ
New York, New York, 10021, United States
Related Publications (1)
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
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 17, 2001
First Posted
August 31, 2001
Study Start
May 1, 2001
Last Updated
June 24, 2005
Record last verified: 2002-05