Status:
COMPLETED
A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Immuno-AG Recombinant HIV gp160 in Asymptomatic HIV Seropositive Individuals
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Immuno-US
Conditions:
HIV Infections
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
To determine the safety and immunogenicity of vaccinia-derived HIV-1 recombinant envelope glycoprotein (gp160) in asymptomatic HIV-infected adult volunteers. To compare safety and immunogenicity of tw...
Detailed Description
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...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
October 1 1998
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00000633
End Date
October 1 1998
Last Update
November 2 2021
Active Locations (2)
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1
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, United States, 21287
2
Washington U CRS
St Louis, Missouri, United States, 63104