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

Information source: Gilead Sciences
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: Truvada (tenofovir DF + emtricitabine) (Drug); Emtriva (emtricitabine) (Drug); Viread (tenofovir DF) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Gilead Sciences

Summary

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.

Clinical Details

Official title: 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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: HIV-1 infection

Secondary outcome: HIV-1 infection in renally impaired HIV infected patients

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Gary Richmond, MD, Fort Lauderdale, Florida 33316, United States

Treasure Coast Infectious Disease Consultants, Vero Beach, Florida 32960, United States

Ronald Reisler, MD, Baltimore, Maryland 21201, United States

Fernando Garcia, MD, Harlingen, Texas 78550, United States

Additional Information

Truvada website

Gilead website

Viread website

Emtriva website

Starting date: October 2004
Last updated: February 1, 2010

Page last updated: August 20, 2015

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