A Two Year Study of the Clinical Efficacy of the Combination of Emtricitabine, Tenofovir, and Nevirapine

NCT00344461 | Completed Phase 4 Results DMC

• 1 other identifier: H-23783
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

Open label, two year study of the clinical efficacy of the combination of FTC, Tenofovir, and Nevirapine. Sixty HIV infected patients without previous exposure to antiretroviral therapy will be enrolled. Study will include a pharmacokinetic substudy to evaluate the interaction of FTC and Nevirapine. Truvada may be used.

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Sustained Virologic Response

  The primary outcome is sustained Virologic response, defined as HIV-1 RNA \<500 copies/mL until trial completion at 96 weeks.

  96 Weeks

Secondary Outcomes (5)

• Patients With Grade 2, 3 and 4 Adverse Events and Laboratory Toxicities

  Protocol length is 96 weeks

• Patients With Plasma HIV RNA < 50 Copies/mL

  96 weeks.

• Patients With Plasma HIV RNA < 400 Copies/mL

  96 weeks

• Change in Plasma HIV RNA From Baseline to Week 96

  Baseline to week 96

• Changes in CD4 Cell Count From Baseline and Week 96

  Baseline to week 96

Study Arms (1)

Nevirapine, FTC, Tenofovir

EXPERIMENTAL

Open Label Drugs- Nevirapine 200 mg twice a day, FTC 200 mg once a day and Tenofovir 300 mg once a day for 96 weeks.

Drug: Nevirapine, FTC, and Tenofovir

Interventions

Nevirapine, FTC, and Tenofovir DRUG

One arm only - Open label using FTC 200 mg p.o. qd, and Tenofovir 300 mg p.o. qd, and Nevirapine 200 mg b.i.d.

Nevirapine, FTC, Tenofovir

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-1 infection, as documented by any licensed ELISA test kit, and confirmed by Western blot, positive HIV-1 blood culture, positive HIV serum antigen, or plasma viremia at any time prior to study entry. If no record exists, testing must occur at screening.
• Male or female, age 18 to 75 years of age.
• Able to sign the informed consent, and is willing to comply with the requirements of this clinical trial.
• Available for at least 96 weeks of follow up.
• Males: deemed a candidate for antiretroviral therapy per referring primary care provider. (If patient is self referred, CD4 cell count must be \<400 cells/mm3 and viral load\>5,000c/ml) Females: CD4 cell count must be less than 250 cells/mm3 and viral load \>5,000 c/mL at time of enrollment.
• If female and of child bearing potential must consent to using at least two forms of contraception.
• Participants will be "treatment naive" as no prior antiretroviral therapy or antiretroviral therapy for less than 7 days in the past.

You may not qualify if:

• Evidence of mutation associated with primary drug resistance to Nevirapine (K103N, Y181C, Y188L, G190S), Tenofovir (M41L, T69 insertion, Q151M, L210W,and K65R), and/or FTC (184V) previously documented, or at time of screening.
• Patients with any of the following laboratory parameters at the screening visit: estimated creatinine clearance of \<60 ml/min; aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2.5 times the upper limits of normal; total bilirubin \>1.5 mg/dL.
• Women with CD4 cell count \> 250 cells/ mm3 at time of entry or in males with a CD4 cell count less than 400/mm3, along with a viral load greater than 5,000c/ml. for both males and females.
• Pregnant women or women who are breast feeding.
• Unwillingness to use effective barrier contraception.
• Patients with current alcohol abuse or illicit drug use that in the opinion of the Principal Investigator may interfere with the patient's ability to comply with the protocol requirements.
• Patients with malabsorption or severe chronic diarrhea for more than 30 days.
• Current treatment for malignancy other than basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
• History of any chronic illness or other condition that in the opinion of the investigator would interfere with the conduct or completion of the study.
• Patient who is, in the opinion of the investigator, unable to complete the 96-week dosing period and protocol evaluations and assessments.
• Experimental vaccines, to include HIV vaccines.
• Patient who is currently enrolled in an experimental protocol, or is receiving an experimental medication.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Boehringer Ingelheim: collaborator

Study Sites (1)

University of Maryland, Institute of Human Virology

Baltimore, Maryland, 21201, United States

Location

Related Publications (1)

• Amoroso A, Gilliam BL, Talwani R, Boyce C, Redfield RR, Davis CE. Viral load decay in antiretroviral-naive patients receiving once-daily tenofovir and emtricitabine plus twice-daily nevirapine. HIV Clin Trials. 2009 Sep-Oct;10(5):320-3. doi: 10.1310/hct1005-320.

  PMID: 19906624 DERIVED

MeSH Terms

Interventions

Nevirapine; Racivir; Tenofovir

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Charles E. Davis, Jr., MD
• Organization: University of Maryland, Institute Of Human Virology

cdavis@ihv.umaryland.edu

410-706-4608

Study Officials

• Robert R Redfield, MD

  University of Maryland, School of Medicine, IHV

  PRINCIPAL INVESTIGATOR

• Charles E Davis, MD

  University of Maryland, School of Medicine, IHV

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2006
• First Posted: June 26, 2006
• Study Start: March 1, 2004
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: November 1, 2021
• Results First Posted: November 14, 2017

Record last verified: 2021-10

Locations

US (1)