Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HE2000-006.4
Study information
Scientific title
Acronym
Study hypothesis
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
Ethics approval
Approved by the Medicines Control Council on 26/09/2000, reference number: N2/19/8/2 (1666)
Study design
Randomised double-blind placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Human immunodeficiency virus (HIV)
Intervention
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
Intervention type
Drug
Phase
Not Specified
Drug names
HE2000
Primary outcome measure
To evaluate the safety and tolerability of up to seven treatment courses of 100 mg of HE2000 administered intramuscularly in late HIV patients
Secondary outcome measures
The assessment of the effect of HE2000 on the incidence rate of opportunistic infections
Overall trial start date
20/11/2000
Overall trial end date
02/12/2002
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant exclusion criteria
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 investigators 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
Recruitment start date
20/11/2000
Recruitment end date
02/12/2002
Locations
Countries of recruitment
South Africa
Trial participating centre
Karl Bremmer Hospital
Cape Town
7531
South Africa
Sponsor information
Organisation
Hollis-Eden Pharmaceuticals, Inc. (USA)
Sponsor details
4435 Eastgate Mall
Suite 400
San Diego
92121
United States of America
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Hollis-Eden Pharmaceuticals, Inc. (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list