Tenofovir DF (Disoproxil Fumarate) in Combination With Emtricitabine in HIV-1 Patients

Study Overview
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Brief Summary
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The purpose of this study is to provide long-term clinical safety and efficacy data for tenofovir disoproxil fumarate and emtricitabine in HIV-infected patients experiencing various degrees of renal impairment.

Detailed Description
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The primary objective of this study is as follows: To evaluate the safety and tolerability of tenofovir following administration of tenofovir disoproxil fumarate 300 mg for 48 weeks in HIV-infected patients experiencing various degrees of renal impairment. The secondary objectives of this study are as follows: To evaluate the safety and tolerability of emtricitabine following administration of emtricitabine 200 mg for 48 weeks in HIV-infected patients experiencing various degrees of renal impairment. To evaluate the efficacy of tenofovir disoproxil fumarate in combination with emtricitabine in renally-impaired HIV-infected patients. To evaluate the pharmacokinetics of tenofovir and emtricitabine in renally-impaired HIV-infected patients.

Official Title
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A Phase 4, Single-Arm Study to Evaluate the Safety, Antiviral Activity and Pharmacokinetics of Tenofovir Disoproxil Fumarate in Combination With Emtricitabine in HIV-1 Infected Patients Experiencing Various Degrees of Renal Impairment

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Truvada (tenofovir DF + emtricitabine)
* Drug: Emtriva (emtricitabine)
* Drug: Viread (tenofovir DF)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible for participation in the study. HIV-1 infection Either antiretroviral therapy-naive requiring antiretroviral treatment with HIV-1 RNA greater than 400 copies/mL or antiretroviral therapy-experienced on a stable antiretroviral regimen for at least 3 mos. with HIV-1 RNA less than or equal to 50 copies/mL at screening. No active opportunistic infection within 45 days prior to baseline. Able to understand and sign the informed consent form and comply with the study. Stable renal impairment within the four defined groups for at least 3 mos., based on creatinine clearance (Cockcroft-Gault method). Exclusion Criteria: Patients who meet any of the following are not to be enrolled in this study. Women who are pregnant or breastfeeding Fanconi syndrome or multiple myeloma, tertiary hyperparathyroidism, malignancy (with the exception of basocellular carcinoma) or myeloproliferative disorder. Women of childbearing potential who are unwilling to use an effective contraceptive method during the study Contraindications to tenofovir DF, emtricitabine or efavirenz Undergoing treatment for tuberculosis Using atazanavir Prior history of mutation M184V, K65R or T69 insertion Z-score on pre-baseline DEXA scan less than -2.5 The following laboratory values within 30 days prior to study entry: *absolute neutrophil count (ANC) less than 750/mm3, *hemoglobin less than 9.0 g/dL, *platelet count less than 50,000/mm3, *AST (SGOT) or ALT (SGPT) less than 5 x ULN and *CD4 cell count less than 100/mm3. Use of nephrotoxic agents or competitors with renal excretions, including aminoglycoside antibiotics, intravenous amphotericin B, cidofovir, cisplatin, foscarnet, intravenous pentamidine, probenecid or other agents with significant nephrotoxic potential Clinically significant cardiac, pulmonary or gastrointestinal disorder Alcohol or drug abuse that could hinder compliance with the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Truvada (tenofovir DF + emtricitabine)|nan|
|Drug: Emtriva (emtricitabine)|nan|
|Drug: Viread (tenofovir DF)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV-1 infection |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV-1 infection in renally impaired HIV infected patients |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV-1, Treatment Naive, Treatment Experienced