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

NCT00344760 | Completed Phase 4 DMC

• 1 other identifier: H-26280
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• 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

  Individual

Secondary Outcomes (11)

• Log viral copy/ml decrease over time during phase 1 and phase 2.

  Over the 48 week study period

• Development of clinical mutations.

  Over the 48 week study period

• Development of sub-clinical mutations (minority variants)

  Over the 48 week study period

• Viral suppression (below 50c/ml) at 24 and 48 weeks.

  At 24 and 48 weeks

• Time to loss of viral response. Loss of viral response defined as:

  Over the 48 week study period

Study Arms (2)

Standard Treatment

ACTIVE COMPARATOR

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

Drug: Efavirenz, lamivudine, and tenofovir

Standard Treatment Plus Enfuvirtide

EXPERIMENTAL

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; Drug: Efavirenz, lamivudine, and tenofovir

Interventions

Enfuvirtide DRUG

subcutaneously twice a day

Also known as: Fuzeon (T-20)

Standard Treatment Plus Enfuvirtide

Efavirenz, lamivudine, and tenofovir DRUG

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

Also known as: Atripla, Epivir and Viread

Standard Treatment; Standard Treatment Plus Enfuvirtide

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland, Institute of Human Virology

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Enfuvirtide; efavirenz; Lamivudine; Tenofovir; Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; HIV Envelope Protein gp41; Viral Fusion Proteins; Membrane Fusion Proteins; Membrane Proteins; Proteins; HIV Antigens; Antigens, Viral; Viral Proteins; env Gene Products, Human Immunodeficiency Virus; Gene Products, env; Retroviridae Proteins; Human Immunodeficiency Virus Proteins; Viral Envelope Proteins; Viral Structural Proteins; Antigens; Biological Factors; Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Oxazines; Emtricitabine; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Ronald B Reisler, MD, MPH

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2006
• First Posted: June 27, 2006
• Study Start: January 1, 2005
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2007
• Last Updated: May 11, 2021

Record last verified: 2021-05

Locations

US (1)