Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002422
Status:
COMPLETED
Last Update Posted:
2009-06-25
First Post:
1999-11-02
Brief Title:
A Study on the Safety and Anti-HIV Activity of HE2000 in HIV-Infected Patients on Salvage Therapy
Sponsor:
Harbor Therapeutics
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase III Open-Label Study of the Safety Tolerance Pharmacokinetics Drug-Interaction and Anti-HIV Activity of Intramuscularly Administered Alpha-Epi-Br HE2000 in HIV-Infected Patients on Salvage Therapy
Status:
COMPLETED
Status Verified Date:
2002-04
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:
The purpose of this study is to see if it is safe and effective to give HE2000 an experimental anti-HIV drug to HIV-infected patients on salvage therapy emergency treatment used when a patient has not responded to standard therapy
HE2000 is a hormone that is suspected to make it more difficult for HIV to live in cells
HE2000 is a hormone that is suspected to make it more difficult for HIV to live in cells
Detailed Description:
HE2000 is a synthetic steroid hormone that when tested in the laboratory had anti-viral activity against wild-type and drug-resistant variants of HIV HE2000 works through a natural biochemical mechanism in cells to make them less able to support viral infection
There are 4 treatment groups of increasing doses of HE2000 each group consists of 2 parts Part A and B Part A is a single administration of HE2000 injected intramuscularly and Part B is 5 consecutive daily intramuscular injections of HE2000 Patients receive the same dosage throughout Parts A and B of the study Patients are asked to return to the clinic periodically for blood sample collection Patients may remain at the hospital overnight for pharmacokinetic evaluation Drug safety tolerance efficacy and pharmacokinetics are measured Samples from treatment Group 4 are analyzed for specific cell function
There are 4 treatment groups of increasing doses of HE2000 each group consists of 2 parts Part A and B Part A is a single administration of HE2000 injected intramuscularly and Part B is 5 consecutive daily intramuscular injections of HE2000 Patients receive the same dosage throughout Parts A and B of the study Patients are asked to return to the clinic periodically for blood sample collection Patients may remain at the hospital overnight for pharmacokinetic evaluation Drug safety tolerance efficacy and pharmacokinetics are measured Samples from treatment Group 4 are analyzed for specific cell function
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HE2000-005 | None | None | None |