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CompletedNCT00002422Updated Jun 25, 2009

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

A Phase 1 interventional study of HE2000 in HIV Infections, sponsored by Harbor Therapeutics. Completed at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-06-25.

Sponsored by Harbor Therapeutics · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
42
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • HIV Infections

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Keywords

  • Injections, Intramuscular
  • Drug Interactions
  • Salvage Therapy
  • Anti-HIV Agents
03

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 42 is below the median of 83 across 3,251 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

Harbor Therapeutics is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Enrollment
42 participants

Interventions

  • DrugHE2000
06

Study locations

6 sites
  • ViRx Inc
    Palm Springs, California 92262, United States
  • Veterans Affairs Palo Alto Health Care Ctr
    Palo Alto, California 94304, United States
  • Quest Clinical Research
    San Francisco, California 94115, United States
  • Northwestern Univ Med School
    Chicago, Illinois 60611, United States
  • St Vincents Hosp / Clinical Research Program
    New York, New York 10011, United States
  • Plaza Med Ctr
    Houston, Texas 77004, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 25, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00002422
Lead sponsor
Harbor Therapeutics
First posted
Aug 31, 2001
Last update
Jun 25, 2009
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2002. You cannot join it, but the record below documents what was studied.

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