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
2 other identifiers
interventional
72
2 countries
34
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 hiv-infections
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
February 1, 1996
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedNovember 3, 2021
October 1, 2021
November 2, 1999
October 27, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication: Recommended:
- PCP prophylaxis.
- Patients must have:
- Documented asymptomatic HIV infection.
- CD4+ count as follows:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, 90801, United States
Childrens Hosp. LA - Dept. of Ped., Div. of Clinical Immunology & Allergy
Los Angeles, California, 900481804, United States
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
Los Angeles, California, 900951752, United States
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
Oakland, California, 946091809, United States
San Francisco Gen. Hosp.
San Francisco, California, 94110, United States
UCSF Pediatric AIDS CRS
San Francisco, California, 941430105, United States
Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
Torrance, California, 905022004, United States
Univ. of Connecticut Health Ctr., Dept. of Ped.
Farmington, Connecticut, 06032, United States
Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
New Haven, Connecticut, 06504, United States
Cook County Hosp.
Chicago, Illinois, 60612, United States
Univ. of Illinois College of Medicine at Chicago, Dept. of Peds.
Chicago, Illinois, 60612, United States
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
Chicago, Illinois, 606143394, United States
Chicago Children's CRS
Chicago, Illinois, 606371470, United States
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana, 701122699, 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, 021155724, United States
BMC, Div. of Ped Infectious Diseases
Boston, Massachusetts, 02118, United States
Baystate Health, Baystate Med. Ctr.
Springfield, Massachusetts, 01199, United States
WNE Maternal Pediatric Adolescent AIDS CRS
Worcester, Massachusetts, 016550001, United States
UMDNJ - Robert Wood Johnson
New Brunswick, New Jersey, United States
NJ Med. School CRS
Newark, New Jersey, 071072198, United States
St. Joseph's Hosp. & Med. Ctr. of New Jersey
Paterson, New Jersey, 07103, United States
SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
Brooklyn, New York, 11203, United States
North Shore-Long Island Jewish Health System, Dept. of Peds.
Great Neck, New York, 11021, United States
NYU Med. Ctr., Dept. of Medicine
New York, New York, 10016, United States
Columbia IMPAACT CRS
New York, New York, 10032, United States
Incarnation Children's Ctr.
New York, New York, 10032, United States
Univ. of Rochester ACTG CRS
Rochester, New York, 14642, United States
SUNY Upstate Med. Univ., Dept. of Peds.
Syracuse, New York, United States
DUMC Ped. CRS
Durham, North Carolina, 277103499, United States
The Children's Hosp. of Philadelphia IMPAACT CRS
Philadelphia, Pennsylvania, 191044318, United States
St. Christopher's Hosp. for Children
Philadelphia, Pennsylvania, 191341095, United States
Texas Children's Hosp. CRS
Houston, Texas, 77030, United States
San Juan City Hosp. PR NICHD CRS
San Juan, 009367344, Puerto Rico
Related Publications (5)
Lambert JS, McNamara J, Katz S, Fenton T, Nichols J, Roberts NJ. Safety and immunogenicity of recombinant envelope HIV vaccines in asymptomatic HIV-infected children. Natl Conf Hum Retroviruses Relat Infect (1st). 1993 Dec 12-16:72
BACKGROUNDLambert JS, et al. Safety and immunogenicity of recombinant envelope HIV vaccines in asymptomatic HIV infected children. Natl Conf Hum Retroviruses Relat Infect (2nd). 1995 Jan 29-Feb 2:151
BACKGROUNDLambert JS, McNamara J, Katz SL, Fenton T, Kang M, VanCott TC, Livingston R, Hawkins E, Moye J Jr, Borkowsky W, Johnson D, Yogev R, Duliege AM, Francis D, Gershon A, Wara D, Martin N, Levin M, McSherry G, Smith G. Safety and immunogenicity of HIV recombinant envelope vaccines in HIV-infected infants and children. National Institutes of Health-sponsored Pediatric AIDS Clinical Trials Group (ACTG-218). J Acquir Immune Defic Syndr Hum Retrovirol. 1998 Dec 15;19(5):451-61. doi: 10.1097/00042560-199812150-00003.
PMID: 9859958BACKGROUNDLambert JS, McNamara J, Katz S, Livingston R, Moye J. Safety and immunogenicity of HIV recombinant envelope vaccines in HIV-infected infants and children. Pediatric AIDS Clinical Trials Group Study ACTG 218. American Pediatric Association and Society for Pediatric Research annual meeting; 1996 May 6-10; Washington, D.C. Pediatr AIDS HIV Infect. 1996 Aug;7(4):279 (unnumbered abstract)
BACKGROUNDLambert JS. HIV vaccines in infants and children. Paediatr Drugs. 2005;7(5):267-76. doi: 10.2165/00148581-200507050-00001.
PMID: 16220994RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Lambert JS
- STUDY CHAIR
Katz S
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
February 1, 1996
Last Updated
November 3, 2021
Record last verified: 2021-10