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ISRCTN
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ISRCTN81525828
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ClinicalTrials.gov identifier
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Public title
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A phase II, randomised, double-blind, placebo-controlled pilot study of the safety, tolerability and activity of intramuscularly administered a-Epi-Br (HE2000) in late stage human immunodeficiency virus-infected patients at risk for opportunistic infections
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Scientific title
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Acronym
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N/A
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Serial number at source
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HE2000-006.4
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Study hypothesis
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1. To evaluate the safety and tolerability of up to seven treatment courses of 100 mg of HE2000
2. To evaluate the effect of HE2000 on the incidence rate, time to resolution and time to recurrence of opportunistic infections in late stage human immunodefiency virus (HIV)-infected patients
3. To assess the effect of repeated administrations of HE2000 (a total of 7 treatment courses) on quality of life
4. To assess the effect of HE2000 on the immune system
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Lay summary
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Ethics approval
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Approved by the Medicines Control Council on 26/09/2000, reference number: N2/19/8/2 (1666)
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Study design
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Randomised double-blind placebo-controlled trial
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Countries of recruitment
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South Africa
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Disease/condition/study domain
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Human immunodeficiency virus (HIV)
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Participants - inclusion criteria
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1. HIV-infected patients who are at least 18 years old with a CD4 cell count ≤100 cell/mm^3 and who are at risk for developing opportunistic infections
2. Karnofsky Performance Score of at least 60 and a life expectancy of at least 6 months
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Participants - exclusion criteria
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1. Patients who have received treatment with chemotherapeutic agents within four weeks of study screen
2. Patients receiving immunomodulatory therapies including interferon, interleukins or steroids (e.g. Moducare, testosterone, deca-durabolin, Dehydroepiandrosterone [DHEA], oxandrolone) within four weeks of the screening visit
3. Patients receiving metabolic inhibitors (e.g. hydroxyurea, cyclophosphamide, methotrexate) within four weeks of the screening visit
4. Patients who are deficient in glucose-6-phosphate dehydrogenase (G6PDH) enzyme
5. Patients with an active, opportunistic infection (OI) requiring acute intervention (i.e. hospitalization) within two weeks of screening; (patients undergoing prophylactic OI treatment or completing OI treatment after resolving the acute phase of the infection are permitted entry in the discretion of the investigator)
6. Patients currently diagnosed, with malignancy including invasive cervical cancer (based on pelvic exam and PAP smear), lymphoma (based on observation and patient history), progressive cytomegalovirus (CMV) disease including CMV-retinitis (based on ophthalmic exam including funduscopy, patient history), Kaposi's sarcoma with visceral involvement (based on physical examination and patient history), HIV-encephalopathy and
acquired immune deficiency syndrome (AIDS)-related dementia (based on investigator’s judgment and patient history)
7. Patients who have acute tuberculosis (TB) or malaria based on laboratory results
8. Patients who have malaria (based on laboratory results)
9. Patients with a malignancy other than cutaneous Kaposi's sarcoma (KS) or basal cell carcinoma
10. Patients with biopsy-confirmed cutaneous KS are eligible at the discretion of the investigator
11. Patients must not have received any systemic therapy for KS within four weeks prior to the screening visit and are not anticipated to require systemic therapy during the course of the study
12. Patients with a clinical condition or receiving therapy that, in the opinion of the investigator, would make the patient unsuitable for study or unable to comply with the dosing requirements
13. Patients who are breast feeding
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Anticipated start date
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20/11/2000
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Anticipated end date
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02/12/2002
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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40
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Interventions
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The treatment course consisted of intramuscular injections, once daily for five days, of either 100 mg of HE2000 or placebo in the control group, followed by a 37-day observation period (6 weeks), for up to seven courses
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Primary outcome measure(s)
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To evaluate the safety and tolerability of up to seven treatment courses of 100 mg of HE2000 administered intramuscularly in late HIV patients
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Secondary outcome measure(s)
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The assessment of the effect of HE2000 on the incidence rate of opportunistic infections
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Sources of funding
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Hollis-Eden Pharmaceuticals, Inc. (USA)
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Trial website
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Publications
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Contact name
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Dr
Zoja
Noveljic
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Address
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Karl Bremmer Hospital
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City/town
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Cape Town
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Zip/Postcode
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7531
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Country
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South Africa
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Sponsor
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Hollis-Eden Pharmaceuticals, Inc. (USA)
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Address
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4435 Eastgate Mall
Suite 400
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City/town
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San Diego
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Zip/Postcode
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92121
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Country
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United States of America
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Sponsor website:
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http://www.holliseden.com
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Date applied
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06/04/2006
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Last edited
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16/10/2009
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Date ISRCTN assigned
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15/05/2006
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