A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Immuno-AG Recombinant HIV gp160 in Asymptomatic HIV Seropositive Individuals

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

Potentiation of a patient's immune response to HIV might possibly prolong the period of clinical latency and protect the patient indefinitely. Preliminary results from a study of Immuno-AG recombinant gp160 vaccine in healthy volunteers not infected with HIV suggest that the vaccine is safe and produces antibodies against the virus. Because another previous study failed to demonstrate a specific anti-HIV response in patients injected with a recombinant vaccinia virus containing HIV-1 genes, this study is also testing the immunotherapeutic role of other immunizations (such as hepatitis B vac...

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Eligibility criteria

• • Inclusion Criteria
• Concurrent Medication: Recommended:
• • Prophylaxis with isoniazid in patients not previously treated.
• Patients must have:
• • HIV seropositivity by Western blot.
• • Normal history and physical exam (generalized lymphadenopathy is acceptable).
• • Mean CD4 cell count = or \> 600 cells/mm3 for all visits (minimum 2 counts) within 60 days prior to study entry, with no single count \< 450 cells/mm3.
• • Negative PPD test or normal chest x-ray with positive PPD (induration = or \> 5 mm).
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• • Hepatitis B surface antigen positive.
• • Evidence of an AIDS- or ARC-defining opportunistic infection.
• • Evidence of disseminated tuberculosis, severe or persistent candidiasis, oral hairy leukoplakia, prolonged or very severe diarrhea, herpes zoster, or herpes simplex persisting more than one month.
• • Active syphilis.
• Patients with the following prior conditions are excluded:
• • Evidence of psychiatric disorder within the past year that would impair adherence to the protocol.
• • History of an AIDS- or ARC-defining opportunistic infection.
• • History of disseminated tuberculosis, severe or persistent candidiasis, oral hairy leukoplakia, prolonged or very severe diarrhea, herpes zoster, or herpes simplex persisting more than one month.
• Prior Medication:
• Excluded:
• • Immunomodulating agents (e.g., isoprinosine, imuthiol, lithium) within 90 days of screening.
• • Immunosuppressive medications within the previous 3 months.
• • Zidovudine (AZT) or any antiviral agent (including interferon) within the previous 6 months.
• • Vaccination against other pathogens within 4 weeks of initial screening laboratory work.
• • Use of illicit drugs or significant amounts of alcohol that could significantly interfere with study compliance.