Status:
COMPLETED
A Two Year Study of the Clinical Efficacy of the Combination of Emtricitabine, Tenofovir, and Nevirapine
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
Boehringer Ingelheim
Conditions:
HIV
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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 enroll...
Detailed Description
Description of study design This is an open-labeled clinical trial evaluating an antiretroviral treatment regimen in which the drugs have demonstrated in vitro activity in both, resting and activated ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00344461
Start Date
March 1 2004
End Date
July 1 2008
Last Update
November 1 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Maryland, Institute of Human Virology
Baltimore, Maryland, United States, 21201