Clinical trial NCT00106379: Tenofovir DF (Disoproxil Fumarate) in Combination With Emtricitabine in HIV-1 Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Keywords: HIV-1
Treatment Naive
Treatment Experienced
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2005-03-24
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: HIV-1 infection
Secondary outcomes:
measure: HIV-1 infection in renally impaired HIV infected patients
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: Gary Richmond, MD
state: Florida
city: Vero Beach
country: United States
facility: Treasure Coast Infectious Disease Consultants
state: Florida
city: Baltimore
country: United States
facility: Ronald Reisler, MD
state: Maryland
city: Harlingen
country: United States
facility: Fernando Garcia, MD
state: Texas
Study officials:
References: