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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00016588

Enrollment

Unknown

Registered

2001-08-31

Start date

2001-05-31

Completion date

Unknown

Last updated

2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

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

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.

Interventions

DRUGTenofovir disoproxil fumarate

Study design

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026