Condition category
Infections and Infestations
Date applied
06/04/2006
Date assigned
15/05/2006
Last edited
16/10/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Zoja Noveljic

ORCID ID

Contact details

Karl Bremmer Hospital
Cape Town
7531
South Africa

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 measures

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

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 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

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

http://www.holliseden.com

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes