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

Completed

• Conditions: Human immunodeficiency virus (HIV); Infections and Infestations

• Registration Number: ISRCTN81525828
• Lead Sponsor: Hollis-Eden Pharmaceuticals, Inc. (USA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-15
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
The assessment of the effect of HE2000 on the incidence rate of opportunistic infections