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

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Maryland; University of Maryland, Baltimore; University of Maryland, College Park
• Collaborator: Boehringer Ingelheim
• Treatments: Nevirapine; Tenofovir

Criteria

Inclusion Criteria:

1. 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.

2. Male or female, age 18 to 75 years of age.

3. Able to sign the informed consent, and is willing to comply with the requirements of this clinical trial.

4. Available for at least 96 weeks of follow up.

5. 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.

6. If female and of child bearing potential must consent to using at least two forms of contraception.

7. Participants will be "treatment naive" as no prior antiretroviral therapy or antiretroviral therapy for less than 7 days in the past.

Exclusion Criteria:

1. 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.

2. 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.

3. 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.

4. Pregnant women or women who are breast feeding.

5. Unwillingness to use effective barrier contraception.

6. 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.

7. Patients with malabsorption or severe chronic diarrhea for more than 30 days.

8. Current treatment for malignancy other than basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.

9. 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.

10. Patient who is, in the opinion of the investigator, unable to complete the 96-week dosing period and protocol evaluations and assessments.

11. Experimental vaccines, to include HIV vaccines.

12. Patient who is currently enrolled in an experimental protocol, or is receiving an experimental medication.