The Safety and Effectiveness of Hyperimmune Anti-HIV Intravenous Immunoglobulin (HVIG) Plus Zidovudine in HIV-Infected Infants
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|ClinicalTrials.gov Identifier: NCT00000961|
Recruitment Status : Terminated
First Posted : August 31, 2001
Last Update Posted : March 14, 2011
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: Anti-HIV Immune Serum Globulin (Human) Drug: Zidovudine||Phase 2|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||112 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Primary Completion Date :||May 1991|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000961
|Study Chair:||Connor E|