Tenofovir Disoproxil Fumarate (TDF) in HIV-1 Patients Who Have Never Taken Anti-HIV Drugs
This study has been completed.
Information provided by:
NIH AIDS Clinical Trials Information Service
First received: May 17, 2001
Last updated: June 23, 2005
Last verified: May 2002
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.
Drug: Tenofovir disoproxil fumarate
||Endpoint Classification: Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
||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 Start Date:
|Ages Eligible for Study:
||18 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00016588
|Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ
|New York, New York, United States, 10021 |
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
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 17, 2001
||June 23, 2005
||United States: Food and Drug Administration
Keywords provided by NIH AIDS Clinical Trials Information Service:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 06, 2014
Acquired Immunodeficiency Syndrome
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Molecular Mechanisms of Pharmacological Action