A Study to Evaluate of the Efficacy of Enfuvirtide During the Induction Phase of Therapy

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

Summary

We hypothesize that using a potent antiretroviral such as Enfuvirtide during the induction phase of HAART therapy will lead to faster clearance of virus and infected cells, and lower number of minority variant HIV-1 strains.

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

Details

• Lead Sponsor: University of Maryland; University of Maryland, Baltimore
• Treatments: Efavirenz; Enfuvirtide; Lamivudine; Tenofovir

Criteria

Inclusion Criteria:

1. Age: 18 to 70 years of age.

2. Sex: Male or Female.

3. Documented HIV-1 seropositive by Western Blot, Elisa, or HIV-1 viral load.

4. Naïve to HAART.

5. Viral load >100,000c/ml.

6. CD4<200c/ml.

7. Volunteers must be willing and able to provide written informed consent to participate in the study.

8. Available for at least 48 weeks of follow-up.

Exclusion Criteria:

1. Volunteers with an acute and clinically significant medical event as determined by the investigator to result in a life expectancy less then 12 months despite ART.

2. Volunteers with current psychiatric illness, alcohol abuse or illicit drug use that in the opinion of the Principal Investigator may interfere with patient's ability to comply with protocol requirements.

3. Renal insufficiency (Estimated Creatinine clearance of <60ml/min.)

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

5. Inability to consume adequate oral intake (defined as inability to eat at least 1 meal per day).

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

7. Any other medical condition which, in the opinion of the investigator, might interfere with completion of the study or evaluation of the results.

8. Pregnancy or breastfeeding

9. In a female capable of child bearing, unwillingness to use effective barrier contraception or abstinence

10. Patient who is currently receiving an experimental medication.