HIV InfectionsPhase 1NCT00000827
A Phase I/II Study of Hyperimmune IVIG in Slowing Progression of Disease in HIV-Infected Children
A Phase 1 study testing Anti-HIV Immune Serum Globulin (Human) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 39 sites in 2 countries.
Trial summary
To evaluate the safety, tolerance, pharmacokinetics, and antiviral activity of human anti-HIV immune serum globulin ( HIVIG ) at three dosage levels in HIV-infected children. Passive antibody therapy has been used with limited success in treating advanced HIV disease in adults. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Anti-HIV Immune Serum Globulin (Human)
- How many people
- 45 participants
- Where
- 39 sitesin 2 countries
- Study dates
- Start not givento Apr 1998
- 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Concurrent Medication:
- Required:
- PCP prophylaxis according to CDC guidelines.
- Allowed:
- Varicella-zoster immunoglobulin.
- Hepatitis B immunoglobulin.
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- Prophylactic therapies not involving immunoglobulin.
- Patients must have:
- HIV infection.
- CD4 count > 200 cells/mm3 (ages 2-5 years) or > 100 cells/mm3 (age > 5 years).
- Antiretroviral therapy for at least 6 months, with no change in regimen for at least 3 months prior to study entry.
- Plasma ICD p24 >= 70 pg/ml that is stable or increasing prior to study entry.
- Life expectancy of at least 6 months.
- Prior Medication: Required:
- Antiretroviral therapy for at least 6 months, with stable dose for at least 3 months.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Severe diarrhea, nephrotic syndrome, or other protein-losing state that requires large doses of IVIG.
- Any other condition requiring dosing with IVIG (e.g., ITP, hypogammaglobulinemia).
- Acute illness with temperature >= 100 F and/or with IV antibiotics.
- Grade 3 or worse clinical toxicities.
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- Unable to tolerate IV infusions at a minimum rate of 0.02 ml/kg/min.
- Concomitant participation in an experimental antiretroviral or HIV vaccine trial.
- Concurrent Medication:
- Excluded:
- IVIG.
- Chemotherapy for an active malignancy.
- MMR or rubella vaccinations.
- Intramuscular immunoglobulin.
- Patients with the following prior condition are excluded:
- History of severe reaction to IVIG.
- Prior Medication:
- Excluded:
- IVIG within the past 60 days.
- Chemotherapy for an active malignancy within the past year.
- MMR or rubella vaccinations within the past 6 months.
- Intramuscular immunoglobulin within the past 60 days.
- Ongoing drug or alcohol abuse.
Trial locations and contacts
39 sites in 2 countries.
39 sites in 2 countries
United States37 sites
Children's Hospital at Albany Medical Center, Dept. of Peds.
Albany, New York, 12208
Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases
Atlanta, Georgia, 30306
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado
Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
Baltimore, Maryland, 21201
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
Baltimore, Maryland
UAB, Dept. of Ped., Div. of Infectious Diseases
Birmingham, Alabama, 35294
BMC, Div. of Ped Infectious Diseases
Boston, Massachusetts
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts
SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
Brooklyn, New York
Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases
Charleston, South Carolina, 29425
Children's Med. Ctr. Dallas
Dallas, Texas, 75235
Children's Hospital of Michigan NICHD CRS
Detroit, Michigan, 48201
Univ. of Connecticut Health Ctr., Dept. of Ped.
Farmington, Connecticut, 06030
North Shore-Long Island Jewish Health System, Dept. of Peds.
Great Neck, New York, 11021
Texas Children's Hosp. CRS
Houston, Texas, 77030
Univ. of Florida Jacksonville NICHD CRS
Jacksonville, Florida, 32209
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, 90801
Usc La Nichd Crs
Los Angeles, California, 90033
Childrens Hosp. LA - Dept. of Ped., Div. of Clinical Immunology & Allergy
Los Angeles, California
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
Los Angeles, California
St. Jude/UTHSC CRS
Memphis, Tennessee
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
Miami, Florida, 33161
Columbia IMPAACT CRS
New York, New York, 10032
Incarnation Children's Ctr.
New York, New York, 10032
Harlem Hosp. Ctr. NY NICHD CRS
New York, New York, 10037
NYU Med. Ctr., Dept. of Medicine
New York, New York
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
Oakland, California
St. Joseph's Hosp. & Med. Ctr. of New Jersey
Paterson, New Jersey
The Children's Hosp. of Philadelphia IMPAACT CRS
Philadelphia, Pennsylvania, 19104
Strong Memorial Hospital Rochester NY NICHD CRS
Rochester, New York
UCSF Pediatric AIDS CRS
San Francisco, California
UW School of Medicine - CHRMC
Seattle, Washington
Baystate Health, Baystate Med. Ctr.
Springfield, Massachusetts, 01199
SUNY Stony Brook NICHD CRS
Stony Brook, New York
Howard Univ. Washington DC NICHD CRS
Washington D.C., District of Columbia, 20060
Children's National Med. Ctr., ACTU
Washington D.C., District of Columbia
WNE Maternal Pediatric Adolescent AIDS CRS
Worcester, Massachusetts
Puerto Rico2 sites
San Juan City Hosp. PR NICHD CRS
San Juan
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
San Juan
About this study
To evaluate the safety, tolerance, pharmacokinetics, and antiviral activity of human anti-HIV immune serum globulin ( HIVIG ) at three dosage levels in HIV-infected children.
Passive antibody therapy has been used with limited success in treating advanced HIV disease in adults. HIVIG is manufactured from HIV antibody-rich plasma taken from asymptomatic donors. It is hypothesized that HIVIG will decrease the viral burden of moderately advanced HIV-positive children.
Read the detailed description
Passive antibody therapy has been used with limited success in treating advanced HIV disease in adults. HIVIG is manufactured from HIV antibody-rich plasma taken from asymptomatic donors. It is hypothesized that HIVIG will decrease the viral burden of moderately advanced HIV-positive children.
Children are randomized to receive HIVIG every 4 weeks for 6 months at one of three dose levels, then are followed for 3 months after the final infusion.
- Conditions
- HIV Infections
- Being tested
- Anti-HIV Immune Serum Globulin (Human)
- Keywords
- Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Immunoglobulins, Intravenous, Immunization, Passive
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-HIV Immune Serum Globulin (Human)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study completionApr 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Enrolment
- 45 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- North American Biologicals Inc
- Responsible party
- Sponsor
- Investigators
- Stiehm ER, Study chairWara DW, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000827
- Sponsor's protocol ID
- ACTG 273
- Other IDs
- 11249
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 4 Nov 2021
- Results posted
- No
Publications
Stiehm ER, Fletcher CV, Mofenson LM, Palumbo PE, Kang M, Fenton T, Sapan CV, Meyer WA, Shearer WT, Hawkins E, Fowler MG, Bouquin P, Purdue L, Sloand EM, Nemo GJ, Wara D, Bryson YJ, Starr SE, Petru A, Burchett S. Use of human immunodeficiency virus (HIV) human hyperimmune immunoglobulin in HIV type 1-infected children (Pediatric AIDS clinical trials group protocol 273). J Infect Dis. 2000 Feb;181(2):548-54. doi: 10.1086/315224.
PubMed 10669338
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Hyperimmune IVIG in Slowing Progression of Disease in HIV-Infected Children
- ClinicalTrials.gov ID
- NCT00000827
- Acronym / sponsor ID
- ACTG 273
- Conditions
- HIV Infections
- Keywords
- Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Immunoglobulins, Intravenous, Immunization, Passive
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- North American Biologicals Inc
- Study completion
- Apr 1998 (actual)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety, tolerance, pharmacokinetics, and antiviral activity of human anti-HIV immune serum globulin ( HIVIG ) at three dosage levels in HIV-infected children.
Passive antibody therapy has been used with limited success in treating advanced HIV disease in adults. HIVIG is manufactured from HIV antibody-rich plasma taken from asymptomatic donors. It is hypothesized that HIVIG will decrease the viral burden of moderately advanced HIV-positive children.
Detailed description
Passive antibody therapy has been used with limited success in treating advanced HIV disease in adults. HIVIG is manufactured from HIV antibody-rich plasma taken from asymptomatic donors. It is hypothesized that HIVIG will decrease the viral burden of moderately advanced HIV-positive children.
Children are randomized to receive HIVIG every 4 weeks for 6 months at one of three dose levels, then are followed for 3 months after the final infusion.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (15 listed)
- PCP prophylaxis according to CDC guidelines.
- Varicella-zoster immunoglobulin.
- Hepatitis B immunoglobulin.
- Prophylactic therapies not involving immunoglobulin.
- HIV infection.
Key exclusion criteria (23 listed)
- Severe diarrhea, nephrotic syndrome, or other protein-losing state that requires large doses of IVIG.
- Any other condition requiring dosing with IVIG (e.g., ITP, hypogammaglobulinemia).
- Acute illness with temperature >= 100 F and/or with IV antibiotics.
- Grade 3 or worse clinical toxicities.
- Unable to tolerate IV infusions at a minimum rate of 0.02 ml/kg/min.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-HIV Immune Serum Globulin (Human) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
- Background: PubMed 10669338Stiehm ER, Fletcher CV, Mofenson LM, Palumbo PE, Kang M, Fenton T, Sapan CV, Meyer WA, Shearer WT, Hawkins E, Fowler MG, Bouquin P, Purdue L, Sloand EM, Nemo GJ, Wara D, Bryson YJ, Starr SE, Petru A, Burchett S. Use of human immunodeficiency virus (HIV) human hyperimmune immunoglobulin in HIV type 1-infected children (Pediatric AIDS clinical trials group protocol 273). J Infect Dis. 2000 Feb;181(2):548-54. doi: 10.1086/315224.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stiehm ER study chair
Wara DW study chair
39 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Anti-HIV Immune Serum Globulin (Human) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 39 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 15 inclusion and 23 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 4 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 39 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 NCT00000827, which also lists 1 linked publication.
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 4 Nov 2021.