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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Abbott Glaxo Wellcome |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000961 |
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 |
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HIV Infections |
Drug: Anti-HIV Immune Serum Globulin (Human) Drug: Zidovudine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Safety 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 |
Estimated Enrollment: | 112 |
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.
Ages Eligible for Study: | up to 3 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Concurrent Treatment:
Allowed:
Patients must have the following:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Concurrent Medication:
Excluded:
Patients with the following are excluded:
Prior Medication:
Excluded:
Study ID Numbers: | ACTG 131 |
Study First Received: | November 2, 1999 |
Last Updated: | August 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00000961 |
Health Authority: | United States: Federal Government |
Drug Therapy, Combination Zidovudine |
Sexually Transmitted Diseases, Viral Acquired Immunodeficiency Syndrome Zidovudine Immunologic Deficiency Syndromes Immune Sera Virus Diseases Antibodies |
HIV Infections Immunoglobulins, Intravenous Sexually Transmitted Diseases Rho(D) Immune Globulin Retroviridae Infections Immunoglobulins |
Antimetabolites Anti-Infective Agents Communicable Diseases RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
Enzyme Inhibitors Infection Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |