HIV InfectionsPhase 2NCT00000961
The Safety and Effectiveness of Hyperimmune Anti-HIV Intravenous Immunoglobulin (HVIG) Plus Zidovudine in HIV-Infected Infants
A Phase 2 study testing Anti-HIV Immune Serum Globulin (Human) and Zidovudine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID).
Trial summary
To determine the safety and tolerance of hyperimmune anti-HIV intravenous immunoglobulin (HIVIG) and of zidovudine (AZT) in infants with established HIV infection; to get preliminary evidence for the effectiveness of this type of treatment in preventing the advance of disease in HIV infected infants. Read more about this study
- Who is it for?
- Ages 1 day to 3 months
- Conditions the study is for
- HIV Infections
- What is being tested?
- Anti-HIV Immune Serum Globulin (Human) and Zidovudine
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- Start not givento May 1991
- Phase
- Phase 2
- 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 day to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Concurrent Medication:
- Allowed:
- Recommended:
- Standard immunizations. Should repeat MMR 3 months after discontinuing study.
- Benadryl and/or aspirin.
- Pneumocystis carinii pneumonia prophylaxis.
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- Systemic ketoconazole and acyclovir, or oral nystatin for acute therapy.
- Aerosol ribavirin for short-term treatment of RSV.
- Concurrent Treatment:
- Allowed:
- Blood transfusion.
- Patients must have the following:
- Parent or guardian available to give written informed consent.
- Protocol requires prior Institutional Review Board (IRB) approval before any subject is entered into study.
- Prior Medication:
- Allowed:
- Gammaglobulin, intravenous (IV) or intramuscular (IM).
- Immunoglobulin, IV (IVIG).
- Maternal antiretroviral treatment during pregnancy.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Symptomatic of any class P-2 symptoms (except lymphadenopathy at time of study entry.
- Presence of serious acute infection requiring parenteral treatment at time of study entry.
- Concurrent Medication:
- Excluded:
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- Prophylaxis for oral candidiasis or otitis media or other infections.
- Immunoglobulin therapy (except single dose or for hypogammaglobulinemia).
- Ketoconazole, acyclovir, or nystatin for prophylaxis.
- Patients with the following are excluded:
- Symptomatic of any class P-2 symptoms (except lymphadenopathy at time of study entry.
- Presence of serious acute infection requiring parenteral treatment at time of study entry.
- Prior Medication:
- Excluded:
- Antiretroviral treatment or experimental treatment within 2 weeks of entry.
About this study
Official title: A Phase II Study to Evaluate the Safety, Tolerance and Efficacy of Hyperimmune Anti-HIV Intravenous Immunoglobulin (HIVIG) and of Zidovudine (ZDV) in Infants With Documented HIV Infections
To determine the safety and tolerance of hyperimmune anti-HIV intravenous immunoglobulin (HIVIG) and of zidovudine (AZT) in infants with established HIV infection; to get preliminary evidence for the effectiveness of this type of treatment in preventing the advance of disease in HIV infected infants. HIVIG may be an effective agent that either alone or in combination with AZT will prevent progression of clinical disease.
Read the detailed description
HIVIG may be an effective agent that either alone or in combination with AZT will prevent progression of clinical disease.
Participants are randomized to receive either oral AZT or HIVIG. Patients may receive treatment for a maximum of 48 weeks. Patients are evaluated during treatment at weeks 2, 4, and every 4 weeks thereafter. Infants who are receiving HIVIG initially are treated with the appropriate age-adjusted dose of oral AZT in addition to HIVIG if they meet clinical disease progression criteria. All participants who have completed 48 weeks of treatment or who are discontinued from treatment are followed every 3 months for an additional 48 weeks. This follow-up may be conducted over the telephone.
- Conditions
- HIV Infections
- Being tested
- Anti-HIV Immune Serum Globulin (Human), Zidovudine
- Keywords
- Drug Therapy, Combination, Zidovudine
- Medical subject headings
- HIV Infections
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
ZidovudineDrug
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)
- Primary completionMay 1991
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 2
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Enrolment
- 112 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Abbott, Glaxo Wellcome
- Investigators
- Connor E, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000961
- Sponsor's protocol ID
- ACTG 131
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 4 Nov 2021
- Results posted
- No
Publications
Spector SA, Gelber RD, McGrath N, Wara D, Barzilai A, Abrams E, Bryson YJ, Dankner WM, Livingston RA, Connor EM. A controlled trial of intravenous immune globulin for the prevention of serious bacterial infections in children receiving zidovudine for advanced human immunodeficiency virus infection. Pediatric AIDS Clinical Trials Group. N Engl J Med. 1994 Nov 3;331(18):1181-7. doi: 10.1056/NEJM199411033311802.
PubMed 7935655
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 II Study to Evaluate the Safety, Tolerance and Efficacy of Hyperimmune Anti-HIV Intravenous Immunoglobulin (HIVIG) and of Zidovudine (ZDV) in Infants With Documented HIV Infections
- ClinicalTrials.gov ID
- NCT00000961
- Acronym / sponsor ID
- ACTG 131
- Conditions
- HIV Infections
- Keywords
- Drug Therapy, Combination, Zidovudine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 112 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Abbott, Glaxo Wellcome
- Primary completion
- May 1991 (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 determine the safety and tolerance of hyperimmune anti-HIV intravenous immunoglobulin (HIVIG) and of zidovudine (AZT) in infants with established HIV infection; to get preliminary evidence for the effectiveness of this type of treatment in preventing the advance of disease in HIV infected infants. HIVIG may be an effective agent that either alone or in combination with AZT will prevent progression of clinical disease.
Detailed description
HIVIG may be an effective agent that either alone or in combination with AZT will prevent progression of clinical disease.
Participants are randomized to receive either oral AZT or HIVIG. Patients may receive treatment for a maximum of 48 weeks. Patients are evaluated during treatment at weeks 2, 4, and every 4 weeks thereafter. Infants who are receiving HIVIG initially are treated with the appropriate age-adjusted dose of oral AZT in addition to HIVIG if they meet clinical disease progression criteria. All participants who have completed 48 weeks of treatment or who are discontinued from treatment are followed every 3 months for an additional 48 weeks. This follow-up may be conducted over the telephone.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 1 day to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (19 listed)
- Recommended:
- Standard immunizations. Should repeat MMR 3 months after discontinuing study.
- Benadryl and/or aspirin.
- Pneumocystis carinii pneumonia prophylaxis.
- Systemic ketoconazole and acyclovir, or oral nystatin for acute therapy.
Key exclusion criteria (15 listed)
- Symptomatic of any class P-2 symptoms (except lymphadenopathy at time of study entry.
- Presence of serious acute infection requiring parenteral treatment at time of study entry.
- Prophylaxis for oral candidiasis or otitis media or other infections.
- Immunoglobulin therapy (except single dose or for hypogammaglobulinemia).
- Ketoconazole, acyclovir, or nystatin for prophylaxis.
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 | – |
| Zidovudine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
- Background: PubMed 7935655Spector SA, Gelber RD, McGrath N, Wara D, Barzilai A, Abrams E, Bryson YJ, Dankner WM, Livingston RA, Connor EM. A controlled trial of intravenous immune globulin for the prevention of serious bacterial infections in children receiving zidovudine for advanced human immunodeficiency virus infection. Pediatric AIDS Clinical Trials Group. N Engl J Med. 1994 Nov 3;331(18):1181-7. doi: 10.1056/NEJM199411033311802.
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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.
Connor E study chair
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anti-HIV Immune Serum Globulin (Human) and Zidovudine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID).
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 19 inclusion and 15 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: stopped early, 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.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early. Results are not available in the source record.
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 NCT00000961, 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.