A Phase I, Dose-Escalating Safety and Tolerance Study of sCD4-PE40 in HIV-Infected Persons
Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001
Trial Information
Current as of May 11, 2025
Completed
Keywords
ClinConnect Summary
There is some evidence that AZT and sCD4-PE40, an experimental drug with anti-HIV activity previously demonstrated in vitro, may produce increased benefit when used in combination in HIV-infected patients.
Cohorts of six patients each receive escalating doses of sCD4-PE40 in a single IV weekly dose for 8 weeks. All six patients at a given dose must complete 2 weeks of therapy without dose-limiting toxicity before dose escalation in subsequent patient cohorts may occur. The MTD is defined as the dose of sCD4-PE40 immediately below that at which two or more of six patients experience grade 3...
Gender
ALL
Eligibility criteria
- • Inclusion Criteria
- Concurrent Medication:
- Allowed:
- • PCP prophylaxis with aerosolized pentamidine, trimethoprim / sulfamethoxazole, or dapsone.
- • Clotrimazole troches or nystatin oral suspension for oral candidiasis.
- • Acyclovir (up to 1000 mg/day for 10 days) for herpes lesions.
- • Erythropoietin.
- Patients must have:
- • Documented HIV infection by ELISA confirmed by a second method. If a prior diagnosis of AIDS has not been established by CDC criteria, a confirmatory test is required.
- • CD4 count = or \< 300 cells/mm3 within 4 weeks prior to study entry.
- • Positive p24 antigen.
- Patients entering the AZT portion of the study only:
- • Must be AZT naive or have had less than 2 months of AZT therapy.
- • Exclusion Criteria
- Co-existing Condition:
- Patients with the following symptoms and conditions are excluded:
- • Hemophilia.
- • Acute medical problems (including active opportunistic infections such as active cryptococcosis, Pneumocystis carinii, herpes zoster, histoplasmosis, or CMV or nonopportunistic diseases including liver disease, renal disease, or orthostatic hypotension) at time of study entry.
- • Active pulmonary disease.
- • Chronic active hepatitis B surface antigenemia or unstable hepatitis C.
- • Current diagnosis of malignancy for which systemic therapy would be required during the study.
- • Inadequate intravenous access.
- Concurrent Medication:
- Excluded:
- • Hepatotoxic agents.
- • Other antiretroviral or immunomodulator agents (including but not limited to AZT, ddI, ddC, interferon, and steroids).
- • Other investigational drugs.
- • Systemic therapy for malignancy.
- • G-CSF and GM-CSF.
- Prior Medication:
- Excluded:
- • Other antiretroviral or immunomodulator agents (including but not limited to AZT, ddI, ddC, interferon, and steroids) within 4 weeks prior to study entry.
- • Ribavirin within 90 days prior to study entry.
- • Cytotoxic chemotherapy within one month prior to study entry.
- • Prior soluble CD4 or CD4-Ig.
- Excluded in patients entering the AZT portion of the study:
- • More than 2 months of prior AZT therapy.
- • Current active alcoholism or active substance abuse.
About National Institute Of Allergy And Infectious Diseases (Niaid)
The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Los Angeles, California, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Chapel Hill, North Carolina, United States
Patients applied
Trial Officials
van der Horst C
Study Chair
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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