A Study on the Safety and Anti-HIV Activity of HE2000 in HIV-Infected Patients on Salvage Therapy
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.
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Primary Purpose: Treatment
|Official Title:||A Phase I/II, 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|
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.
|United States, California|
|Palm Springs, California, United States, 92262|
|Veterans Affairs Palo Alto Health Care Ctr|
|Palo Alto, California, United States, 94304|
|Quest Clinical Research|
|San Francisco, California, United States, 94115|
|United States, Illinois|
|Northwestern Univ Med School|
|Chicago, Illinois, United States, 60611|
|United States, New York|
|St Vincents Hosp / Clinical Research Program|
|New York, New York, United States, 10011|
|United States, Texas|
|Plaza Med Ctr|
|Houston, Texas, United States, 77004|