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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
HE2000
Sponsored by
Harbor Therapeutics
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Injections, Intramuscular, Drug Interactions, Salvage Therapy, Anti-HIV Agents

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • ViRx Inc
  • Veterans Affairs Palo Alto Health Care Ctr
  • Quest Clinical Research
  • Northwestern Univ Med School
  • St Vincents Hosp / Clinical Research Program
  • Plaza Med Ctr

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 24, 2009
Sponsor
Harbor Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT00002422
Brief Title
A Study on the Safety and Anti-HIV Activity of HE2000 in HIV-Infected Patients on Salvage Therapy
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2002
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Harbor Therapeutics

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Injections, Intramuscular, Drug Interactions, Salvage Therapy, Anti-HIV Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
42 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
HE2000

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
ViRx Inc
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Veterans Affairs Palo Alto Health Care Ctr
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Quest Clinical Research
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Northwestern Univ Med School
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
St Vincents Hosp / Clinical Research Program
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Plaza Med Ctr
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States

12. IPD Sharing Statement

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

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