Human immunodeficiency virus (HIV) Infections and Infestations
Conditions
Interventions
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
Sponsors
Hollis-Eden Pharmaceuticals, Inc. (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of up to seven treatment courses of 100 mg of HE2000 administered intramuscularly in late HIV patients | — |
Secondary
| Measure | Time frame |
|---|---|
| The assessment of the effect of HE2000 on the incidence rate of opportunistic infections | — |
Countries
South Africa
Outcome results
None listed