NCT00106379

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_4 hiv-infections

Timeline
Completed

Started Oct 2004

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 24, 2005

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

February 2, 2010

Status Verified

April 1, 2008

First QC Date

March 23, 2005

Last Update Submit

February 1, 2010

Conditions

HIV Infections

Keywords

HIV-1Treatment NaiveTreatment Experienced

Outcome Measures

Primary Outcomes (1)

  • HIV-1 infection

Secondary Outcomes (1)

  • HIV-1 infection in renally impaired HIV infected patients

Interventions

Truvada (tenofovir DF + emtricitabine)DRUG
Emtriva (emtricitabine)DRUG
Viread (tenofovir DF)DRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Gary Richmond, MD

Fort Lauderdale, Florida, 33316, United States

Location

Treasure Coast Infectious Disease Consultants

Vero Beach, Florida, 32960, United States

Location

Ronald Reisler, MD

Baltimore, Maryland, 21201, United States

Location

Fernando Garcia, MD

Harlingen, Texas, 78550, United States

Location

Related Links

MeSH Terms

Conditions

HIV Infections

Interventions

Emtricitabine, Tenofovir Disoproxil Fumarate Drug CombinationTenofovirEmtricitabine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDrug CombinationsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 23, 2005

First Posted

March 24, 2005

Study Start

October 1, 2004

Study Completion

January 1, 2007

Last Updated

February 2, 2010

Record last verified: 2008-04

Locations

US(4)