Home | All trials

[RDF data]
Trial NCT00000633

Resource URI: http://static.linkedct.org/resource/trials/NCT00000633
PropertyValue
linkedct:brief_title A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Immuno-AG Recombinant HIV gp160 in Asymptomatic HIV Seropositive Individuals
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/5445>
linkedct:condition <http://static.linkedct.org/resource/condition/5486>
linkedct: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.
linkedct: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 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. 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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 60 Years
linkedct:eligibility_minimum_age 18 Years
linkedct:enrollment 55 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:id NCT00000633
rdfs:label Trial NCT00000633
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency Immuno-US
linkedct:location <http://static.linkedct.org/resource/location/163103>
linkedct:location <http://static.linkedct.org/resource/location/163631>
linkedct:location <http://static.linkedct.org/resource/location/168367>
linkedct:location <http://static.linkedct.org/resource/location/179052>
linkedct:location <http://static.linkedct.org/resource/location/194183>
linkedct:nct_id NCT00000633
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Immuno-AG Recombinant HIV gp160 in Asymptomatic HIV Seropositive Individuals
linkedct:org_study_id ACTG 205
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/53261>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/3038>
foaf:page <http://clinicaltrials.gov/show/NCT00000633>
linkedct:phase Phase 1
linkedct:reference <http://static.linkedct.org/resource/reference/46590>
linkedct:reference <http://static.linkedct.org/resource/reference/48060>
linkedct:secondary_id AVEG 101
linkedct:source National Institute of Allergy and Infectious Diseases (NIAID)
linkedct:study_design Treatment, Placebo Control, Safety Study
linkedct:study_type Interventional
linkedct: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 two different schedules of gp160 administration. To examine the effects of gp160 and hepatitis B vaccine (Engerix-B) on various markers of viral load and on selected immune parameters. 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.
rdf:type linkedct:trials
linkedct:verification_date October 2002