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A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Immuno-AG Recombinant HIV gp160 in Asymptomatic HIV Seropositive Individuals Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Immuno-AG Recombinant HIV gp160 in Asymptomatic HIV Seropositive Individuals conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Immuno-AG Recombinant HIV gp160 in Asymptomatic HIV Seropositive Individuals Clinical research trials and A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Immuno-AG Recombinant HIV gp160 in Asymptomatic HIV Seropositive Individuals health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Immuno-AG Recombinant HIV gp160 in Asymptomatic HIV Seropositive Individuals. A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Immuno-AG Recombinant HIV gp160 in Asymptomatic HIV Seropositive Individuals Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Immuno-AG Recombinant HIV gp160 in Asymptomatic HIV Seropositive Individuals clinical trial. Human subjects often get the best healthcare available for their A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Immuno-AG Recombinant HIV gp160 in Asymptomatic HIV Seropositive Individuals condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Immuno-AG Recombinant HIV gp160 in Asymptomatic HIV Seropositive Individuals  A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Immuno-AG Recombinant HIV gp160 in Asymptomatic HIV Seropositive Individuals
A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Immuno-AG Recombinant HIV gp160 in Asymptomatic HIV Seropositive Individuals
For Condition: HIV Infections
Status: Completed
Sponsor(s): Immuno-US , National Institute of Allergy and Infectious Diseases (NIAID)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Placebo Control, Safety Study
Minimum Age/Maximum Age: 18 Years/60 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 55
Location and Contact Information:
Overall Study Official:
SchwartzD, Study Chair,
St Louis Univ School of Medicine
St. Louis, Missouri, 63104
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Johns Hopkins Univ / School of Hygiene & Public Health
Baltimore, Maryland, 212051901
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Vanderbilt Univ Hosp
Nashville, Tennessee, 37232
United States
Additional Information:
Study ID Numbers: ACTG 205; AVEG 101
Study Start Date:
Record last reviewed: October 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000633
Other Hiv Infections Studies:
1. A Comparison of the Effectiveness, Safety, and Tolerability of Two Different Hepatitis C Treatments in Patients Infected with Both HIV and Hepatitis C Virus (HCV)
2. A Phase II/III Trial of Human Anti-CMV Monoclonal Antibody MSL 109 (MACRT)
3. Ganciclovir: Compassionate Use in Patients With Serious or Life-Threatening Cytomegalovirus Infections
4. A Study of CI-1012 in HIV-Infected Patients
5. Safety and Effectiveness of the Drug DPC 083 in Combination with Nucleoside Analogue Reverse Transcriptase Inhibitors in HIV-1-Infected Patients Who Are Failing Treatment with Nonnucleoside Reverse Transcriptase Inhibitors
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A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Immuno-AG Recombinant HIV gp160 in Asymptomatic HIV Seropositive Individuals
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