Clinical trial NCT00002422: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: Injections, Intramuscular
Drug Interactions
Salvage Therapy
Anti-HIV Agents
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Palm Springs
country: United States
facility: ViRx Inc
state: California
city: Palo Alto
country: United States
facility: Veterans Affairs Palo Alto Health Care Ctr
state: California
city: San Francisco
country: United States
facility: Quest Clinical Research
state: California
city: Chicago
country: United States
facility: Northwestern Univ Med School
state: Illinois
city: New York
country: United States
facility: St Vincents Hosp / Clinical Research Program
state: New York
city: Houston
country: United States
facility: Plaza Med Ctr
state: Texas
Study officials:
References: