Back to resultsA Study to Evaluate of the Efficacy of Enfuvirtide During the Induction Phase of Therapy
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Enfuvirtide
Efavirenz, lamivudine, and tenofovir
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections
Eligibility Criteria
Inclusion Criteria: Age: 18 to 70 years of age. Sex: Male or Female. Documented HIV-1 seropositive by Western Blot, Elisa, or HIV-1 viral load. Naïve to HAART. Viral load >100,000c/ml. CD4<200c/ml. Volunteers must be willing and able to provide written informed consent to participate in the study. Available for at least 48 weeks of follow-up. Exclusion Criteria: 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. 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. Renal insufficiency (Estimated Creatinine clearance of <60ml/min.) Patients with malabsorption or severe chronic diarrhea for more than 30 days. Inability to consume adequate oral intake (defined as inability to eat at least 1 meal per day). Current treatment for malignancy other than basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix. Any other medical condition which, in the opinion of the investigator, might interfere with completion of the study or evaluation of the results. Pregnancy or breastfeeding In a female capable of child bearing, unwillingness to use effective barrier contraception or abstinence Patient who is currently receiving an experimental medication.
Sites / Locations
- University of Maryland, Institute of Human Virology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard Treatment
Standard Treatment Plus Enfuvirtide
Arm Description
Efavirenz 600mg once daily, Lamivudine 300mg once daily and Tenofovir 300mg once daily
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).
Outcomes
Primary Outcome Measures
Time to viral suppression below 50c/ml.
The study is 48 weeks long and the time to viraL suppression will vary depending on the subject. Or there is the possibility that they do not supress
Secondary Outcome Measures
Log viral copy/ml decrease over time during phase 1 and phase 2.
Development of clinical mutations.
Development of sub-clinical mutations (minority variants)
Viral suppression (below 50c/ml) at 24 and 48 weeks.
Time to loss of viral response. Loss of viral response defined as:
Less then 2.0 log decrease in viral load at week 8.
Inability to achieve Viral load <50c/ml by week 12.
Viral load >50c/ml on 2 consecutive measurements taken 2 weeks apart after viral
suppression <50c/ml has occurred
Rate and quantity of HIV-1 proviral DNA decay.
Safety and tolerability.
Full Information
NCT ID
NCT00344760
First Posted
June 23, 2006
Last Updated
May 6, 2021
Sponsor
University of Maryland, Baltimore
1. Study Identification
Unique Protocol Identification Number
NCT00344760
Brief Title
A Study to Evaluate of the Efficacy of Enfuvirtide During the Induction Phase of Therapy
Official Title
Viral Decay Kinetics During Induction Therapy With or Without the Use of Enfuvirtide in HAART-naÃ-ve Patients With Advanced HIV
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Maryland, Baltimore
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard Treatment
Arm Type
Active Comparator
Arm Description
Efavirenz 600mg once daily, Lamivudine 300mg once daily and Tenofovir 300mg once daily
Arm Title
Standard Treatment Plus Enfuvirtide
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Enfuvirtide
Other Intervention Name(s)
Fuzeon (T-20)
Intervention Description
subcutaneously twice a day
Intervention Type
Drug
Intervention Name(s)
Efavirenz, lamivudine, and tenofovir
Other Intervention Name(s)
Atripla, Epivir and Viread
Intervention Description
Efavirenz -600mg once daily, lamivudine- 300mg once daily, and tenofovir 300mg once daily
Primary Outcome Measure Information:
Title
Time to viral suppression below 50c/ml.
Description
The study is 48 weeks long and the time to viraL suppression will vary depending on the subject. Or there is the possibility that they do not supress
Time Frame
Individual
Secondary Outcome Measure Information:
Title
Log viral copy/ml decrease over time during phase 1 and phase 2.
Time Frame
Over the 48 week study period
Title
Development of clinical mutations.
Time Frame
Over the 48 week study period
Title
Development of sub-clinical mutations (minority variants)
Time Frame
Over the 48 week study period
Title
Viral suppression (below 50c/ml) at 24 and 48 weeks.
Time Frame
At 24 and 48 weeks
Title
Time to loss of viral response. Loss of viral response defined as:
Time Frame
Over the 48 week study period
Title
Less then 2.0 log decrease in viral load at week 8.
Time Frame
Week 8
Title
Inability to achieve Viral load <50c/ml by week 12.
Time Frame
Week 12
Title
Viral load >50c/ml on 2 consecutive measurements taken 2 weeks apart after viral
Time Frame
Over the 48 week study period
Title
suppression <50c/ml has occurred
Time Frame
Over the 48 week study period
Title
Rate and quantity of HIV-1 proviral DNA decay.
Time Frame
Over the 48 week study period
Title
Safety and tolerability.
Time Frame
Over the 48 week study period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age: 18 to 70 years of age.
Sex: Male or Female.
Documented HIV-1 seropositive by Western Blot, Elisa, or HIV-1 viral load.
Naïve to HAART.
Viral load >100,000c/ml.
CD4<200c/ml.
Volunteers must be willing and able to provide written informed consent to participate in the study.
Available for at least 48 weeks of follow-up.
Exclusion Criteria:
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.
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.
Renal insufficiency (Estimated Creatinine clearance of <60ml/min.)
Patients with malabsorption or severe chronic diarrhea for more than 30 days.
Inability to consume adequate oral intake (defined as inability to eat at least 1 meal per day).
Current treatment for malignancy other than basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
Any other medical condition which, in the opinion of the investigator, might interfere with completion of the study or evaluation of the results.
Pregnancy or breastfeeding
In a female capable of child bearing, unwillingness to use effective barrier contraception or abstinence
Patient who is currently receiving an experimental medication.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald B Reisler, MD, MPH
Organizational Affiliation
University of Maryland, School of Medicine, Department of Infectious Disease
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland, Institute of Human Virology
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate of the Efficacy of Enfuvirtide During the Induction Phase of Therapy
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