Tenofovir DF (Disoproxil Fumarate) in Combination With Emtricitabine in HIV-1 Patients
This study has been completed.
Sponsor:
Gilead Sciences
Information provided by:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00106379
First received: March 23, 2005
Last updated: February 1, 2010
Last verified: April 2008
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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 4 |
| 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
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 |
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:
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 |
Tenofovir disoproxil 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 May 16, 2013