Tenofovir Disoproxil Fumarate (TDF) in HIV-1 Patients Who Have Never Taken Anti-HIV Drugs
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: May 17, 2001
Last updated: June 23, 2005
Last Verified: May 2002
History of Changes
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
Masking: None (Open Label)
Primary Purpose: Treatment
|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|
Further study details as provided by NIH AIDS Clinical Trials Information Service:
|Study Start Date:||May 2001|
Patients receive TDF.Eligibility
|Ages Eligible for Study:||18 Years to 65 Years|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
- 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
Patients will not be eligible for this study if they:
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00016588
Locations Show More
|United States, New York|
|Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ|
|New York, New York, United States, 10021|
Sponsors and CollaboratorsGilead Sciences
|Responsible Party:||Gilead Sciences|
|ClinicalTrials.gov Identifier:||NCT00016588 History of Changes|
|Other Study ID Numbers:||283H|
|Study First Received:||May 17, 2001|
|Last Updated:||June 23, 2005|
Keywords provided by NIH AIDS Clinical Trials Information Service:HIV-1
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on July 20, 2018
This information is provided by ClinicalTrials.gov.