The Safety and Effectiveness of Hyperimmune Anti-HIV Intravenous Immunoglobulin (HVIG) Plus Zidovudine in HIV-Infected Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infections

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Drug Therapy, Combination Zidovudine

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Anti-HIV Immune Serum Globulin (Human)

Intervention Type DRUG

Zidovudine

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Concurrent Medication:

Allowed:

* 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.
* 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.

Exclusion Criteria

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:

* 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.

Minimum Eligible Age

1 Day

Maximum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Connor E

Role: STUDY_CHAIR

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND

PMID: 7935655 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ACTG 131

Identifier Type: -

Identifier Source: org_study_id