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

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ClinicalTrials.gov Identifier: NCT00344760
Recruitment Status : Completed
First Posted : June 27, 2006
Last Update Posted : February 8, 2013
Sponsor:
Information provided by:
University of Maryland

Study Description
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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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Enfuvirtide Drug: Efavirenz, lamivudine, and tenofovir Phase 4

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).


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Viral Decay Kinetics During Induction Therapy With or Without the Use of Enfuvirtide in HAART-naÃ-ve Patients With Advanced HIV
Study Start Date : January 2005
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Standard Treatment
Efavirenz 600mg once daily, Lamivudine 300mg once daily and Tenofovir 300mg once daily
 Drug: Efavirenz, lamivudine, and tenofovir
Efavirenz -600mg once daily, lamivudine- 300mg once daily, and tenofovir 300mg once daily
Other Name: Atripla, Epivir and Viread
Experimental: 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).
 Drug: Enfuvirtide
subcutaneously twice a day
Other Name: Fuzeon (T-20)
Drug: Efavirenz, lamivudine, and tenofovir
Efavirenz -600mg once daily, lamivudine- 300mg once daily, and tenofovir 300mg once daily
Other Name: Atripla, Epivir and Viread


Outcome Measures
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Primary Outcome Measures :
  1. Time to viral suppression below 50c/ml. [ Time Frame: Individual ]
    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 :
  1. Log viral copy/ml decrease over time during phase 1 and phase 2. [ Time Frame: Over the 48 week study period ]
  2. Development of clinical mutations. [ Time Frame: Over the 48 week study period ]
  3. Development of sub-clinical mutations (minority variants) [ Time Frame: Over the 48 week study period ]
  4. Viral suppression (below 50c/ml) at 24 and 48 weeks. [ Time Frame: At 24 and 48 weeks ]
  5. Time to loss of viral response. Loss of viral response defined as: [ Time Frame: Over the 48 week study period ]
  6. Less then 2.0 log decrease in viral load at week 8. [ Time Frame: Week 8 ]
  7. Inability to achieve Viral load <50c/ml by week 12. [ Time Frame: Week 12 ]
  8. Viral load >50c/ml on 2 consecutive measurements taken 2 weeks apart after viral [ Time Frame: Over the 48 week study period ]
  9. suppression <50c/ml has occurred [ Time Frame: Over the 48 week study period ]
  10. Rate and quantity of HIV-1 proviral DNA decay. [ Time Frame: Over the 48 week study period ]
  11. Safety and tolerability. [ Time Frame: Over the 48 week study period ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00344760


Locations
United States, Maryland
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Dr. Ronald Reisler, Institute of Human Virology
ClinicalTrials.gov Identifier: NCT00344760     History of Changes
Other Study ID Numbers: H-26280
First Posted: June 27, 2006    Key Record Dates
Last Update Posted: February 8, 2013
Last Verified: February 2013

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Tenofovir
Lamivudine
Efavirenz
Enfuvirtide
Antiviral Agents
Anti-Infective Agents
 Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers
HIV Fusion Inhibitors
Viral Fusion Protein Inhibitors