A Study on the Safety and Anti-HIV Activity of HE2000 in HIV-Infected Patients on Salvage Therapy - Full Text View

Sponsor:	Harbor BioSciences, Inc
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002422

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: HE2000	Phase I

Study Type:	Interventional
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

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: Drug Reactions HIV/AIDS HIV/AIDS Medicines

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:

42

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

Are at least 18 years old.
Are HIV-positive.
Have been on their current anti-HIV drug combination for at least 30 days prior to the screening visit.
Are currently failing at least their second anti-HIV drug treatment.
Are not responding to their current anti-HIV treatment, have failed at least 1 anti-HIV combination, and do not have many options for treatment (Groups 3 and 4 only).
Are willing to not make any changes in their anti-HIV treatment until at least Day 50 during the study.
Have a CD4 count of at least 100 cells/mm3 at study entry.
Have a viral load (level of HIV in the body) between 5,000 and 250,000 copies/ml at study entry.
Agree to use barrier methods of birth control (e.g., condoms) during the study.

Exclusion Criteria

Patients will not be eligible for this study if they:

Have hepatitis B or C.
Have been treated for cancer within 4 weeks prior to study entry, or will need to be treated during the study. (Patients with Kaposi's sarcoma are eligible but must not have received any treatment within 4 weeks before study entry or require treatment during the study.)
Have received certain medications including those affecting the immune system.
Are pregnant or breast-feeding.
Have an active, serious infection, including opportunistic (AIDS-defining) infection that requires treatment during the study or during the 2 weeks prior to study entry.
Have a condition or are receiving therapy that would prevent them from completing the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002422

Locations

United States, California
ViRx Inc
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

Sponsors and Collaborators

Harbor BioSciences, Inc

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00002422 History of Changes
Other Study ID Numbers:	303A, HE2000-005
Study First Received:	November 2, 1999
Last Updated:	June 24, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Injections, Intramuscular
Drug Interactions
Salvage Therapy
Anti-HIV Agents

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases

Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on February 09, 2012