The Safety and Effectiveness of Hyperimmune Anti-HIV Intravenous Immunoglobulin (HVIG) Plus Zidovudine in HIV-Infected Infants
This study has been terminated.
Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators:
Abbott
Glaxo Wellcome
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000961
First received: November 2, 1999
Last updated: March 11, 2011
Last verified: March 1998
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Anti-HIV Immune Serum Globulin (Human) Drug: Zidovudine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):
| Estimated Enrollment: | 112 |
| Primary Completion Date: | May 1991 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | up to 3 Months (Child) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000961
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000961
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Abbott
Glaxo Wellcome
Investigators
| Study Chair: | Connor E |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00000961 History of Changes |
| Other Study ID Numbers: | ACTG 131 |
| Study First Received: | November 2, 1999 |
| Last Updated: | March 11, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
Drug Therapy, Combination Zidovudine |
Additional relevant MeSH terms:
|
Infection HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Immunoglobulins Antibodies Immunoglobulins, Intravenous |
Gamma-Globulins Rho(D) Immune Globulin Immune Sera Zidovudine Immunologic Factors Physiological Effects of Drugs Antimetabolites Molecular Mechanisms of Pharmacological Action Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents |
ClinicalTrials.gov processed this record on September 26, 2016