- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000961
The Safety and Effectiveness of Hyperimmune Anti-HIV Intravenous Immunoglobulin (HVIG) Plus Zidovudine in HIV-Infected Infants
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Interventional Model: Parallel Assignment
Collaborators and Investigators
Investigators
- Study Chair: Connor E
Publications and helpful links
Study record dates
Study Major Dates
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Infections
- Acquired Immunodeficiency Syndrome
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antimetabolites
- Immunologic Factors
- Zidovudine
- Immune Sera
Other Study ID Numbers
- ACTG 131
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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