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

Sponsor:	Gilead Sciences
Information provided by:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT00106379

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: Truvada (tenofovir DF + emtricitabine) Drug: Emtriva (emtricitabine) Drug: Viread (tenofovir DF)	Phase IV

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

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Tenofovir Tenofovir disoproxil Tenofovir Disoproxil Fumarate Truvada

U.S. FDA Resources

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:

HIV-1 infection

Secondary Outcome Measures:

HIV-1 infection in renally impaired HIV infected patients

Estimated Enrollment:	52
Study Start Date:	October 2004
Study Completion Date:	January 2007

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

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00106379

Locations

United States, Florida
Gary Richmond, MD
Fort Lauderdale, Florida, United States, 33316
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, United States, 32960
United States, Maryland
Ronald Reisler, MD
Baltimore, Maryland, United States, 21201
United States, Texas
Fernando Garcia, MD
Harlingen, Texas, United States, 78550

Sponsors and Collaborators

Gilead Sciences

More Information

Additional Information:

Truvada website This link exits the ClinicalTrials.gov site

Gilead website This link exits the ClinicalTrials.gov site

Viread website This link exits the ClinicalTrials.gov site

Emtriva website This link exits the ClinicalTrials.gov site

Study Results This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00106379 History of Changes
Other Study ID Numbers:	GS-104-0235
Study First Received:	March 23, 2005
Last Updated:	February 1, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Gilead Sciences:

HIV-1
Treatment Naive
Treatment Experienced

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Tenofovir disoproxil

Tenofovir
Emtricitabine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on February 12, 2012