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

NCT ID: NCT00344760

Last Updated: 2021-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2007-03-31

Brief 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.

Detailed Description

This is an 48 week Phase 4, open label, randomized, prospective, pilot proof of concept study to evaluate the use of Enfuvirtide in an induction/maintenance treatment model. Patients meeting inclusion criteria will be stratified into two groups according to HIV-1 RNA viral loads (less than 300,000 copies/ml and greater than 300,000 copies/ml). Thereafter, patients will be block randomized (the size of each block will be two patients) into one of two treatment arms.

All patients will receive Efavirenz 600mg once a day, Lamivudine 300 mg once a day, and Tenofovir 300mg once a day. After randomization, one half of the patients will receive no additional treatment, while the other half will receive Enfuvirtide 90mg sq BID until the viral load is <50 x 2 consecutive visits or 12 weeks (whichever comes first).

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard Treatment

Efavirenz 600mg once daily, Lamivudine 300mg once daily and Tenofovir 300mg once daily

Group Type: ACTIVE_COMPARATOR

Efavirenz, lamivudine, and tenofovir

Intervention Type: DRUG

Efavirenz -600mg once daily, lamivudine- 300mg once daily, and tenofovir 300mg once daily

Standard Treatment Plus Enfuvirtide

Efavirenz 600mg once daily, Lamivudine 300mg once daily, Tenofovir 300mg once daily and enfuvirtide 90mg subcutaneously twice a day until the viral load is less than 50copies for 2 consecutive visits or 12 weeks (whichever comes first).

Group Type: EXPERIMENTAL

Enfuvirtide

Intervention Type: DRUG

subcutaneously twice a day

Efavirenz, lamivudine, and tenofovir

Intervention Type: DRUG

Efavirenz -600mg once daily, lamivudine- 300mg once daily, and tenofovir 300mg once daily

Interventions

Enfuvirtide

subcutaneously twice a day

Intervention Type: DRUG

Efavirenz, lamivudine, and tenofovir

Efavirenz -600mg once daily, lamivudine- 300mg once daily, and tenofovir 300mg once daily

Intervention Type: DRUG

Other Intervention Names

Fuzeon (T-20); Atripla, Epivir and Viread

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronald B Reisler, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, School of Medicine, Department of Infectious Disease

Locations

University of Maryland, Institute of Human Virology

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

H-26280

Identifier Type: -

Identifier Source: org_study_id