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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

This study has been completed.
Sponsor:
Collaborators:
Genentech, Inc.
MicroGeneSys Inc (nka Protein Sciences Corporation)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000762
First received: November 2, 1999
Last updated: May 22, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
HIV Infections
Biological: rgp120/HIV-1MN
Biological: rgp120/HIV-1 SF-2
Biological: gp160 Vaccine (MicroGeneSys)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 72
Study Completion Date: February 1996
Detailed Description:

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, dose escalation to the higher dose of that vaccine is initiated in subsequent patient cohorts, provided all low dose arms are filled. A total of six immunizations are given, at 0, 4, 8, 12, 16, and 24 weeks. Patients are followed for 24 weeks after the last immunization.

  Eligibility

Ages Eligible for Study:   1 Month to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000762

  Show 34 Study Locations
Sponsors and Collaborators
Genentech, Inc.
MicroGeneSys Inc (nka Protein Sciences Corporation)
Investigators
Study Chair: Lambert JS
Study Chair: Katz S
  More Information

Publications:
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
Lambert 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
Lambert 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)

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000762     History of Changes
Other Study ID Numbers: ACTG 218, 11195
Study First Received: November 2, 1999
Last Updated: May 22, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Vaccines, Synthetic
HIV Envelope Protein gp160
HIV Envelope Protein gp120
AIDS Vaccines
HIV Therapeutic Vaccine

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Communicable Diseases
HIV Infections
Infection
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014