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A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Vaccine Component P3C541b in HIV-1 Seronegative Human Subjects Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Vaccine Component P3C541b in HIV-1 Seronegative Human Subjects conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Vaccine Component P3C541b in HIV-1 Seronegative Human Subjects Clinical research trials and A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Vaccine Component P3C541b in HIV-1 Seronegative Human Subjects health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Vaccine Component P3C541b in HIV-1 Seronegative Human Subjects. A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Vaccine Component P3C541b in HIV-1 Seronegative Human Subjects Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Vaccine Component P3C541b in HIV-1 Seronegative Human Subjects clinical trial. Subjects frequently get the best healthcare possible for their A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Vaccine Component P3C541b in HIV-1 Seronegative Human Subjects condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Vaccine Component P3C541b in HIV-1 Seronegative Human Subjects  A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Vaccine Component P3C541b in HIV-1 Seronegative Human Subjects
A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Vaccine Component P3C541b in HIV-1 Seronegative Human Subjects
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To evaluate an HIV synthetic lipopeptide candidate vaccine component, P3C541b, at two dose levels, administered subcutaneously (s.c.) in a randomized, double-blind, placebo controlled study.
Details: The prospective volunteers will be screened and HLA typed for Class I MHC haplotypes. Only volunteers possessing HLA alleles A33, B8, B27, B35 or Bw62 or any combination thereof will be enrolled in the study. Subjects will be allocated to 1 of 2 study groups. Group 1 will receive 70 mcg of P3C541b or the placebo and Group II will receive 350 mcg of P3C541b or the placebo. NOTE: Enrollment for Group II wil not begin until at least 5 Group I participants have reached day 14 without serious adverse events.
Eligibility:
Study Type: Interventional, Prevention, Double-Blind, Safety Study
Minimum Age/Maximum Age: 18 Years/60 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have or be: - Healthy - Negative ELISA for HIV. - One or more HLA alleles: - A33, B8, B27, B35, or Bw62. - Negative for Hepatitis B surface antigen. - Normal urine dipstick. - Normal history and physical examination. - Availability for follow-up planned duration of the study (12 months). - Viable EBV line prior to enrollment. Risk behavior: Required: - Lower risk sexual behavior as defined by AVEG. Exclusion Criteria Co-existing Condition: Patients with any of the following symptoms or conditions are excluded: - Medical or psychiatric condition or occupational responsibilities, which preclude subject compliance with the protocol (e.g., recent suicidal ideation or present psychosis). - Active syphilis. NOTE: If the serology is documented to be false positive due to a remote (> 6 months) treated infection, the volunteer is eligible. - Hepatitis B surface antigenemia. - Active tuberculosis. NOTE: Volunteers with a positive PPD and a normal chest X-Ray showing no evidence of TB and not requiring INH therapy are eligible. Patients with any of the following prior conditions are excluded: - History of immunodeficiency, chronic illness, malignancy, autoimmune disease. - History of cancer, unless there has been surgical excision followed by a sufficient observation period to give a reasonable assurance of a cure. - History of anaphylaxis or history of other serious adverse reactions to vaccines. - History of serious allergic reaction to any substance, requiring hospitalization or emergent medical care. - History of suicide attempts or past psychosis. Prior Medication: Excluded: - History of use of immunosuppressive medication. - Live attenuated vaccines within 60 days of study. NOTE: - Medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) are not exclusionary but should be given at least 2 weeks away from HIV immunizations. - Use of experimental agents within 30 days prior to study. Prior Treatment: Excluded: - Receipt of blood products or immunoglobulin in the past 6 months. Risk Behavior: Excluded: - Subjects with identifiable higher risk behavior for HIV infection as determined by screening questionnaire designed to identify risk factors for HIV infection. - History of injection drug use within the last 12 months prior to enrollment. - Higher or intermediate risk sexual behavior as defined by AVEG.
Total Enrollment: 30
Location and Contact Information:
Overall Study Official:
SchwartzD, Study Chair,
Univ of Washington / Pacific Med Ctr
Seattle, Washington, 98144
United States
Vanderbilt Univ Hosp
Nashville, Tennessee, 37232
United States
Johns Hopkins Univ / School of Hygiene & Public Health
Baltimore, Maryland, 212051901
United States
Additional Information:
Study ID Numbers: AVEG 021;
Study Start Date:
Record last reviewed: October 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000845
Other Hiv Infections Studies:
1. Follow-up Protocol for Patients with Cancer/AIDS/Skin Disease
2. A Randomized, Controlled, Multicenter Trial of Filgrastim (Recombinant-methionyl Human Granulocyte Colony Stimulating Factor; G-CSF) for the Prevention of Grade 4 Neutropenia in Patients With HIV Infection.
3. Prospective Study of HIV Infection in Hemophiliacs
4. A Phase I Study of the Safety and Immunogenicity of rgp 120/HIV-1IIIB Vaccine in HIV-1 Seropositive Adult Volunteers
5. The Safety and Effectiveness of Didanosine Plus Stavudine Plus Nevirapine Combined with MKC-442 in HIV-Infected Patients Who Have Not Had Success with Protease Inhibitors
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A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Vaccine Component P3C541b in HIV-1 Seronegative Human Subjects
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