A Study to Evaluate of the Efficacy of Enfuvirtide During the Induction Phase of Therapy - Full Text View

Sponsored by:	University of Maryland
Information provided by:	University of Maryland
ClinicalTrials.gov Identifier:	NCT00344760

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: Enfuvirtide	Phase IV

MedlinePlus related topics: AIDS

Drug Information available for: Enfuvirtide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	Viral Decay Kinetics During Induction Therapy With or Without the Use of Enfuvirtide in HAART-naÃ-ve Patients With Advanced HIV

Further study details as provided by University of Maryland:

Primary Outcome Measures:

Time to viral suppression below 50c/ml.

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.

Estimated Enrollment:	20
Study Start Date:	January 2005
Study Completion Date:	March 2007
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

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).

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00344760

Locations

United States, Maryland
University of Maryland, Institute of Human Virology
Baltimore, Maryland, United States, 21201
University of Maryland, Institute of Human Virology
Baltimore, Maryland, United States, 21201

Sponsors and Collaborators

University of Maryland

Investigators

Principal Investigator:

Ronald B Reisler, MD, MPH

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

More Information

Study ID Numbers:	H-26280
Study First Received:	June 23, 2006
Last Updated:	October 8, 2008
ClinicalTrials.gov Identifier:	NCT00344760
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Enfuvirtide
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Anti-HIV Agents
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Infection

Antiviral Agents
Pharmacologic Actions
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
HIV Fusion Inhibitors

ClinicalTrials.gov processed this record on January 13, 2009