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AzTrials

HIV InfectionsPhase 1NCT00000762

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

A Phase 1 study testing rgp120/HIV-1MN, rgp120/HIV-1 SF-2 and gp160 Vaccine (MicroGeneSys) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 34 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 month to 18 years
Conditions the study is for
HIV Infections
What is being tested?
rgp120/HIV-1MN, rgp120/HIV-1 SF-2 and gp160 Vaccine (MicroGeneSys)
Type of treatment
Vaccines
How many people
72 participants
Where
34 sitesin 2 countries
Study dates
Start not givento Feb 1996
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 month to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • Co-existing Condition:
  • Patients with the following condition are excluded:
  • Any serious acute infection.
  • Concurrent Medication:
  • Excluded:
  • Anticipated steroid therapy of > 6 weeks duration.
Show all 12Show fewer
  • 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 locations and contacts

34 sites in 2 countries.

34 sites in 2 countries

United States33 sites

  • Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases

    Baltimore, Maryland

  • HMS - Children's Hosp. Boston, Div. of Infectious Diseases

    Boston, Massachusetts, 021155724

  • BMC, Div. of Ped Infectious Diseases

    Boston, Massachusetts, 02118

  • SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS

    Brooklyn, New York, 11203

  • Cook County Hosp.

    Chicago, Illinois, 60612

  • Univ. of Illinois College of Medicine at Chicago, Dept. of Peds.

    Chicago, Illinois, 60612

  • Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease

    Chicago, Illinois, 606143394

  • Chicago Children's CRS

    Chicago, Illinois, 606371470

  • DUMC Ped. CRS

    Durham, North Carolina, 277103499

  • Univ. of Connecticut Health Ctr., Dept. of Ped.

    Farmington, Connecticut, 06032

  • North Shore-Long Island Jewish Health System, Dept. of Peds.

    Great Neck, New York, 11021

  • Texas Children's Hosp. CRS

    Houston, Texas, 77030

  • Long Beach Memorial Med. Ctr., Miller Children's Hosp.

    Long Beach, California, 90801

  • Childrens Hosp. LA - Dept. of Ped., Div. of Clinical Immunology & Allergy

    Los Angeles, California, 900481804

  • UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS

    Los Angeles, California, 900951752

  • UMDNJ - Robert Wood Johnson

    New Brunswick, New Jersey

  • Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease

    New Haven, Connecticut, 06504

  • Tulane/LSU Maternal/Child CRS

    New Orleans, Louisiana, 701122699

  • NYU Med. Ctr., Dept. of Medicine

    New York, New York, 10016

  • Columbia IMPAACT CRS

    New York, New York, 10032

  • Incarnation Children's Ctr.

    New York, New York, 10032

  • NJ Med. School CRS

    Newark, New Jersey, 071072198

  • Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.

    Oakland, California, 946091809

  • St. Joseph's Hosp. & Med. Ctr. of New Jersey

    Paterson, New Jersey, 07103

  • The Children's Hosp. of Philadelphia IMPAACT CRS

    Philadelphia, Pennsylvania, 191044318

  • St. Christopher's Hosp. for Children

    Philadelphia, Pennsylvania, 191341095

  • Univ. of Rochester ACTG CRS

    Rochester, New York, 14642

  • San Francisco Gen. Hosp.

    San Francisco, California, 94110

  • UCSF Pediatric AIDS CRS

    San Francisco, California, 941430105

  • Baystate Health, Baystate Med. Ctr.

    Springfield, Massachusetts, 01199

  • SUNY Upstate Med. Univ., Dept. of Peds.

    Syracuse, New York

  • Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases

    Torrance, California, 905022004

  • WNE Maternal Pediatric Adolescent AIDS CRS

    Worcester, Massachusetts, 016550001

Other trials in United States

Puerto Rico1 site

  • San Juan City Hosp. PR NICHD CRS

    San Juan, 009367344

Other trials in Puerto Rico

About this study

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.

Read the 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.

Conditions
HIV Infections
Being tested
rgp120/HIV-1MN, rgp120/HIV-1 SF-2, gp160 Vaccine (MicroGeneSys)
Keywords
Vaccines, Synthetic, HIV Envelope Protein gp160, HIV Envelope Protein gp120, AIDS Vaccines, HIV Therapeutic Vaccine
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rgp120/HIV-1MNBiological

  • rgp120/HIV-1 SF-2Biological

  • gp160 Vaccine (MicroGeneSys)Biological

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2001 (estimated)
  2. Study completionFeb 1996

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Masking
Double blind
Enrolment
72 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000762
Sponsor's protocol ID
ACTG 218
Other IDs
11195
Status last verified
Oct 2021
First submitted
2 Nov 1999
Last updated
3 Nov 2021
Results posted
No

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 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.

    PubMed 9859958

  • 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)

  • Lambert JS. HIV vaccines in infants and children. Paediatr Drugs. 2005;7(5):267-76. doi: 10.2165/00148581-200507050-00001.

    PubMed 16220994

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing rgp120/HIV-1MN, rgp120/HIV-1 SF-2 and gp160 Vaccine (MicroGeneSys) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 34 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00000762, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2021.

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