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A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Immunotherapeutic P3C541b in HIV-1 Seropositive Human Subjects Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Immunotherapeutic P3C541b in HIV-1 Seropositive 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 Immunotherapeutic P3C541b in HIV-1 Seropositive Human Subjects Clinical research trials and A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Immunotherapeutic P3C541b in HIV-1 Seropositive Human Subjects health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Immunotherapeutic P3C541b in HIV-1 Seropositive Human Subjects. A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Immunotherapeutic P3C541b in HIV-1 Seropositive Human Subjects Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Immunotherapeutic P3C541b in HIV-1 Seropositive Human Subjects clinical trial. Human subjects often get the best healthcare possible for their A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Immunotherapeutic P3C541b in HIV-1 Seropositive Human Subjects condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed 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 Immunotherapeutic P3C541b in HIV-1 Seropositive Human Subjects  A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Immunotherapeutic P3C541b in HIV-1 Seropositive Human Subjects
A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Immunotherapeutic P3C541b in HIV-1 Seropositive Human Subjects
For Condition: HIV Infections
Status: Completed
Sponsor(s): United Biomedical ,
Synopsis: To evaluate an HIV lipopeptide immunotherapeutic, P3C541b, at two dose levels administered subcutaneously in HIV-seropositive patients.
Details: Patients are randomized to receive P3C541b or placebo within each of two study groups. Enrollment in the first group will be independent of HLA type, whereas all but two of the patients enrolled in group 2 must have one or more HLA types A33, B8, B27, or Bw62. Treatment in group 2 will not begin until those in group 1 have reached day 14 without serious toxicity.
Eligibility:
Study Type: Interventional, Treatment, Placebo Control, Safety Study
Minimum Age/Maximum Age: 18 Years/60 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - HIV positivity. - CD4 count >= 500 cells/mm3. - No evidence of AIDS, persistent diarrhea, fever, oral hairy leukoplakia, herpes varicella-zoster (multidermatomal), oral candidiasis, opportunistic infections, severe cytomegalovirus infection, or disseminated or chronic herpes simplex. - Successful establishment of EBV transformed B lymphoblastoid cell line. NOTE: - Most patients in group 2 must possess one or more HLA types A33, B8, B27, or Bw62. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Active syphilis. - Positive circulating hepatitis B virus antigen. - Active clinically significant medical problems. - Evidence of psychiatric, medical, or substance abuse problems that would affect ability to participate on study. - Occupational or other responsibilities that would prevent completion of study. Concurrent Medication: Excluded: - Other HIV immunotherapeutic. - Zidovudine or analog. - Investigational therapies for HIV. Patients with the following prior conditions are excluded: - History of cancer unless surgically excised with reasonable assurance of cure. - History of anaphylaxis or other serious adverse reactions to vaccines. - History of serious allergic reaction to any substance that required hospitalization or emergent medical care (e.g., Stevens-Johnson syndrome, bronchospasms, or hypotension). - History of autoimmune disease or use of immunosuppressive medications. - History of suicide attempts or past psychosis. Prior Medication: Excluded within the past 6 months: - HIV immunotherapeutic. - Zidovudine or analog. - Investigational therapies for HIV. Illicit drug use within past 30 days.
Total Enrollment:
Location and Contact Information:
Beth Israel Hosp
Boston, Massachusetts, 02215
United States
Additional Information:
Study ID Numbers: 090; V103B
Study Start Date:
Record last reviewed: July 1997
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002353
Other Hiv Infections Studies:
1. Increasing Condom Use in People at Risk for HIV Infection
2. A Phase I Study of Combination Therapy With Didanosine (ddI) and Ribavirin in HIV-Infected Children.
3. Combination Treatment Using Capravirine (AG1549), Nelfinavir, and Two Nucleoside Reverse Transcriptase Inhibitors in HIV Patients Who Failed Initial Combination Therapy
4. The Safety and Effectiveness of Interferon Alfa-2B Plus Didanosine in Patients with Kaposi's Sarcoma
5. The Safety and Effectiveness of Retrovir Plus HIVID Combined with Either Nevirapine or Invirase in the Treatment of HIV Infection
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A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Immunotherapeutic P3C541b in HIV-1 Seropositive Human Subjects
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