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Phase I Safety Study of anti-HIV Immune Serum Globulin (Human)



Phase I Safety Study of anti-HIV Immune Serum Globulin (Human)

For Condition: HIV Infections
Status: Completed
Sponsor(s): Abbott Laboratories ,
Synopsis: To investigate the potential benefit of providing passive immunity with hyperimmune anti-HIV human serum.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - Proof of HIV infection. - Diagnosis of asymptomatic HIV infection or early AIDS related complex (ARC) with no zidovudine (AZT) or other anti-HIV therapy. OR a diagnosis of AIDS and = or > 3 months of AZT therapy. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: - HIV-induced neurological disease. - IgA negative. Concurrent Medication: Excluded: - Immunomodulating agents. - Steroids. - Interferons. Patients with the following are excluded: - Active substance abuse. - Use of immunomodulating drugs such as steroids or interferons. - HIV-induced neurological disease. - IgA negative. Required with a diagnosis of AIDS: - = or > 3 months of zidovudine (AZT) therapy. Active substance abuse.
Total Enrollment: 12

Location and Contact Information:

Univ of Minnesota
Minneapolis,  Minnesota,  55455
United States
 


Additional Information:
Study ID Numbers:
  060A;  0001-008
Study Start Date: 
Record last reviewed: February 1990
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002036

Other Hiv Infections Studies:
1. Effect of Vaccination on Turnover of Lamivudine (3TC) Sensitive and Resistant Virus Populations in HIV-1-Infected Individuals

2. Evaluation of the Safety and Tolerance of Immunotherapy With Autologous, Ex-Vivo Expanded, HIV-Specific Cytotoxic T-Cells in HIV-Infected Patients With CD4+ Counts Between 100-400/mm3

3. A Pilot Study of the Short-Term Effects of Antiretroviral Management Based on Plasma Genotypic Antiretroviral Resistance Testing (GART) Compared With Antiretroviral Management Without Plasma GART

4. Quality of Life in Children with HIV Infection

5. The Pharmacokinetics of Zidovudine and Oxazepam Alone and in Combination in the HIV-Infected Patient

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Phase I Safety Study of anti-HIV Immune Serum Globulin (Human)

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