Fuzeon (Enfuvirtide) Early Access Program for Patients With HIV-1 Infection
|First Received Date ICMJE||December 23, 2002|
|Last Updated Date||March 3, 2008|
|Start Date ICMJE||November 2002|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00050856 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Fuzeon (Enfuvirtide) Early Access Program for Patients With HIV-1 Infection|
|Official Title ICMJE||Multicenter, Open-Label, Early Acces Program of Fuzeon (Enfuvirtide T-20/Ro 29,9800, HIV-1 Fusion Inhibitor) in Combination With Free Choice Antiretroviral Regimen to Assess Serious Adverse Events, Serious AIDS-Defining Events, and Tolerability in Patient|
This study will determine the safety and tolerability of Fuzeon (enfuvirtide) used together with other treatments for HIV infection in patients with advanced HIV disease. Fuzeon is an antiretroviral drug. Unlike other antiretrovirals, however, which work against the virus once it is already in the cell, Fuzeon prevents the virus from getting into healthy cells.
Patients 18 years of age and older with advanced HIV-1 infection, who do not respond to approved antiretroviral therapy, may be eligible for this study. Candidates must have a CD4 lymphocyte count less than 100 cells/mm3 and a viral load greater than 10,000 copies/mL. They will be screened with a medical history, physical examination, and blood tests, and may also have an electrocardiogram (ECG), chest x-ray and urine test.
Patients enrolled in the study will be re-examined and have additional blood tests before beginning treatment with Fuzeon. They will then be taught how to self-inject the medicine under the skin and will take two doses daily (less than 1/4 teaspoon each), 12 hours apart. After the first treatment, participants will have follow-up visits at weeks 1, 2, 4, 8, 12, 24, 36, 48, and every 12 weeks after that, if necessary, until 12 weeks after the drug becomes commercially available. Visits may be scheduled more often if a problem arises. During the follow-up visits, patients will have blood drawn, and their blood pressure, pulse rate and temperature will be checked. They will also report any drug side effects they have experienced.
Patients may continue to take Fuzeon as long as they benefit from therapy and do not experience severe side effects from the treatment. The drug will be provided to participants until 12 weeks after it is sold in the United States.
Over the last few years, an unprecedented decrease in the mortality and morbidity associated with AIDS has been achieved attributed to the use of highly active antiretroviral therapy (HAART) which consists of three different classes of drugs: Nucleoside reverse transcriptase inhibitors (NRTIs), protease inhibitors (PIs), and non-nucleoside reverse transcriptase inhibitors (NNRTIs). However, the durability of viral suppression is often limited by treatment with combinations of non-fully suppressive antiretroviral agents. Heavily pretreated patients often possess multiple mutations of the reverse transcriptase and protease genes resulting in multi-drug resistance. Thus, a pharmacological agent effective at an alternate point in the virus replication cycle would make a valuable addition to the anti-HIV armamentarium. T-20, enfuvirtide, is the first drug to be developed which specifically inhibits the function of the gp41 transmembrane glycoprotein of HIV-1. The objective of this study is to assess the safety and tolerability of Fuzeon (Enfuvirtide) in patients who are limited by the current commercially available antiretroviral agents or agents available via early access or compassionate use programs as per the judgment of the investigator or patients with advanced disease and most in need of therapy. This study is a multicenter, open-label, single-arm, safety study. Each patient will receive enfuvirtide 90 mg (deliverable dose) via subcutaneous injection twice daily with food, in combination additional antiretroviral agents. Subjects will continue to receive enfuvirtide until 12 weeks after commercial availability of enfuvirtide in the United States. Laboratory testing, CD4+lymphocyte counts, HIV-1 viral loads will be monitored on a regular and continual basis. The main outcome measures are ones of safety and tolerability: serious adverse events (including all deaths, serious AIDS defining events, and discontinuations for any reason), injection reconstitution fatigue.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Endpoint Classification: Efficacy Study
Primary Purpose: Treatment
|Condition ICMJE||HIV Infections|
|Intervention ICMJE||Drug: Enfuvirtide T/20/Ro 29,9800, HIV-1 Infusion Inhibitor|
|Study Arm (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||November 2003|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
To be eligible for this trial, patients must fulfill all inclusion criteria listed below:
Patients meeting any of the following exclusion criteria will not be eligible for participation in this trial:
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00050856|
|Other Study ID Numbers ICMJE||030056, 03-I-0056|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Allergy and Infectious Diseases (NIAID)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||November 2003|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP