Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00050856
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2002-12-23
Brief Title:
Fuzeon Enfuvirtide Early Access Program for Patients With HIV-1 Infection
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Multicenter Open-Label Early Acces Program of Fuzeon Enfuvirtide T-20Ro 299800 HIV-1 Fusion Inhibitor in Combination With Free Choice Antiretroviral Regimen to Assess Serious Adverse Events Serious AIDS-Defining Events and Tolerability in Patient
Status:
COMPLETED
Status Verified Date:
2003-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 cellsmm3 and a viral load greater than 10000 copiesmL 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 14 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
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 cellsmm3 and a viral load greater than 10000 copiesmL 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 14 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
Detailed Description:
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 CD4lymphocyte 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-I-0056 | None | None | None |