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

Study Overview
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Brief Summary
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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
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Patients receive TDF.

Official Title
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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

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Tenofovir disoproxil fumarate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tenofovir disoproxil fumarate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV-1, Adenine, Anti-HIV Agents, Viral Load, Organophosphorus Compounds