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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00106379
Recruitment Status : Completed
First Posted : March 24, 2005
Last Update Posted : February 2, 2010
Information provided by:
Gilead Sciences

Brief 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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Truvada (tenofovir DF + emtricitabine) Drug: Emtriva (emtricitabine) Drug: Viread (tenofovir DF) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 52 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2004
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Primary Outcome Measures :
  1. HIV-1 infection

Secondary Outcome Measures :
  1. HIV-1 infection in renally impaired HIV infected patients

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00106379

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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
Additional Information:
Layout table for additonal information Identifier: NCT00106379    
Other Study ID Numbers: GS-104-0235
First Posted: March 24, 2005    Key Record Dates
Last Update Posted: February 2, 2010
Last Verified: April 2008
Keywords provided by Gilead Sciences:
Treatment Naive
Treatment Experienced
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents