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

Completed · Phase 1

Conditions studied: HIV Infections

In brief

To determine the safety and immunogenicity of gp160 (MicroGeneSys), rgp120/HIV-1MN (Genentech), and rgp120/HIV-1SF2 (BIOCINE) and their adjuvants in HIV-infected children 1 month to 18 years of age. 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.

Key facts

Study ID

NCT00000762

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

72

Expected to finish

1996-02-01

Last updated by the study team

2021-11-03

Who can join

Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Long Beach Memorial Med. Ctr., Miller Children's Hosp. — Long Beach, California, United States
• Childrens Hosp. LA - Dept. of Ped., Div. of Clinical Immunology & Allergy — Los Angeles, California, United States
• UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS — Los Angeles, California, United States
• Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab. — Oakland, California, United States
• San Francisco Gen. Hosp. — San Francisco, California, United States
• UCSF Pediatric AIDS CRS — San Francisco, California, United States
• Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases — Torrance, California, United States
• Univ. of Connecticut Health Ctr., Dept. of Ped. — Farmington, Connecticut, United States
• Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease — New Haven, Connecticut, United States
• Cook County Hosp. — Chicago, Illinois, United States
• Univ. of Illinois College of Medicine at Chicago, Dept. of Peds. — Chicago, Illinois, United States
• Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease — Chicago, Illinois, United States
• Chicago Children's CRS — Chicago, Illinois, United States
• Tulane/LSU Maternal/Child CRS — New Orleans, Louisiana, United States
• Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases — Baltimore, Maryland, United States
• HMS - Children's Hosp. Boston, Div. of Infectious Diseases — Boston, Massachusetts, United States
• BMC, Div. of Ped Infectious Diseases — Boston, Massachusetts, United States
• Baystate Health, Baystate Med. Ctr. — Springfield, Massachusetts, United States
• WNE Maternal Pediatric Adolescent AIDS CRS — Worcester, Massachusetts, United States
• UMDNJ - Robert Wood Johnson — New Brunswick, New Jersey, United States
• NJ Med. School CRS — Newark, New Jersey, United States
• St. Joseph's Hosp. & Med. Ctr. of New Jersey — Paterson, New Jersey, United States
• SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS — Brooklyn, New York, United States
• North Shore-Long Island Jewish Health System, Dept. of Peds. — Great Neck, New York, United States
• NYU Med. Ctr., Dept. of Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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