A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Immuno-AG Recombinant HIV gp160 in Asymptomatic HIV Seropositive Individuals
NCT ID: NCT00000633
Last Updated: 2021-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
55 participants
INTERVENTIONAL
1998-10-31
Brief Summary
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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 vaccination) that would be expected to induce a nonspecific immune response in HIV-infected persons.
Detailed Description
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Fifty-five healthy HIV-positive volunteers are randomly assigned to one of the following treatment arms: six injections (arm I) or four injections (arm II) of HIV-1 gp160 vaccine, four injections of hepatitis B vaccine as a non-HIV viral vaccine control (arm III), or six placebo injections consisting of the adjuvant vehicle used for the gp160 vaccine (arm IV). Immunizations or placebo are given at 4-week intervals for 5 months. To maintain blinding, adjuvant vehicle placebo is administered on days 84 and 112 to those volunteers receiving four instead of six vaccine injections (arms II and III). Volunteers are followed at 4-month intervals for 2 years.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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gp160 Vaccine (Immuno-AG)
Hepatitis B Vaccine (Recombinant)
Eligibility Criteria
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Inclusion Criteria
* 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
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.
18 Years
60 Years
ALL
No
Sponsors
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Immuno-US
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Schwartz D
Role: STUDY_CHAIR
Locations
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Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, United States
Washington U CRS
St Louis, Missouri, United States
Countries
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References
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Keefer MC, Graham BS, Belshe RB, Schwartz D, Corey L, Bolognesi DP, Stablein DM, Montefiori DC, McElrath MJ, Clements ML, et al. Studies of high doses of a human immunodeficiency virus type 1 recombinant glycoprotein 160 candidate vaccine in HIV type 1-seronegative humans. The AIDS Vaccine Clinical Trials Network. AIDS Res Hum Retroviruses. 1994 Dec;10(12):1713-23. doi: 10.1089/aid.1994.10.1713.
Belshe RB, Clements ML, Dolin R, Graham BS, McElrath J, Gorse GJ, Schwartz D, Keefer MC, Wright P, Corey L, et al. Safety and immunogenicity of a fully glycosylated recombinant gp160 human immunodeficiency virus type 1 vaccine in subjects at low risk of infection. National Institute of Allergy and Infectious Diseases AIDS Vaccine Evaluation Group Network. J Infect Dis. 1993 Dec;168(6):1387-95. doi: 10.1093/infdis/168.6.1387.
Other Identifiers
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11182
Identifier Type: REGISTRY
Identifier Source: secondary_id
AVEG 101
Identifier Type: -
Identifier Source: secondary_id
ACTG 205
Identifier Type: -
Identifier Source: org_study_id