A Placebo-Controlled, Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Envelope Proteins of HIV-1 gp160 and gp120 in Children >= 1 Month Old With Asymptomatic HIV Infection
Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001
Trial Information
Current as of January 15, 2025
Completed
Keywords
ClinConnect Summary
The initiation of this immunotherapy trial will provide multiple benefits by assessing in asymptomatic HIV-infected children a therapy currently being tested in their adult counterparts, in the hope of forestalling the progression of HIV immunosuppression and clinical disease.
Patients are randomized to receive one of three vaccines (9 patients/vaccine) or the adjuvant placebos (3 patients/vaccine). The vaccines will be studied at both low and high doses. When three of four patients at the low dose of a vaccine have received two immunizations without evidence of dose-limiting toxicity, dos...
Gender
ALL
Eligibility criteria
- • Inclusion Criteria
- Concurrent Medication: Recommended:
- • PCP prophylaxis.
- Patients must have:
- • Documented asymptomatic HIV infection.
- * CD4+ count as follows:
- • 1-11 months of age must have \> 2000 cells/mm3 and \>= 30 percent of the total lymphocytes; 12-23 months must have \> 1000 cells/mm3 and \>= 20 percent of the total lymphocytes; 24 months-6 years must have \> 750 cells/mm3 and \>= 20 percent of the total lymphocytes; and 7 years and older must have \> 500 cells/mm3 and \>= 20 percent of the total lymphocytes.
- NOTE:
- • Patients who received zidovudine for 3 consecutive months immediately prior to study entry may receive only high doses of vaccine.
- • Exclusion Criteria
- Co-existing Condition:
- Patients with the following condition are excluded:
- • Any serious acute infection.
- Concurrent Medication:
- Excluded:
- • Anticipated steroid therapy of \> 6 weeks duration.
- Excluded within the past 2 years:
- • More than one serious proven bacterial infection such as sepsis, pneumonia, meningitis, bone or joint infection, abscess of an internal organ or body cavity (other than otitis media or superficial skin or mucosal abscesses) caused by Haemophilus, Streptococcus, Pneumococcus, or other pyogenic bacteria.
- Prior Medication:
- Excluded:
- • Antiretroviral therapy or immunomodulators (e.g., IVIG) within 1 month prior to study entry (NOTE: AZT is allowed within 1 month prior to study entry if patient is entering a high-dose arm).
- • Uninterrupted steroid therapy of \> 6 weeks duration.
Trial Officials
Lambert JS
Study Chair
Katz S
Study Chair
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
Oakland, California, United States
New Orleans, Louisiana, United States
Boston, Massachusetts, United States
Newark, New Jersey, United States
New York, New York, United States
Rochester, New York, United States
Los Angeles, California, United States
San Francisco, California, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Springfield, Massachusetts, United States
Worcester, Massachusetts, United States
New Brunswick, New Jersey, United States
Brooklyn, New York, United States
Great Neck, New York, United States
New York, New York, United States
Durham, North Carolina, United States
Philadelphia, Pennsylvania, United States
Houston, Texas, United States
San Juan, , Puerto Rico
Long Beach, California, United States
Torrance, California, United States
Chicago, Illinois, United States
Paterson, New Jersey, United States
New York, New York, United States
Syracuse, New York, United States
Philadelphia, Pennsylvania, United States
Los Angeles, California, United States
San Francisco, California, United States
Farmington, Connecticut, United States
New Haven, Connecticut, United States
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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