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A Phase I Comparative Blinded Trial of Several HIV-1 Derived Immunogens in Infected Individuals With >= 500 CD4 Cells/mm3 Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on A Phase I Comparative Blinded Trial of Several HIV-1 Derived Immunogens in Infected Individuals With >= 500 CD4 Cells/mm3 conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. A Phase I Comparative Blinded Trial of Several HIV-1 Derived Immunogens in Infected Individuals With >= 500 CD4 Cells/mm3 Clinical research trials and A Phase I Comparative Blinded Trial of Several HIV-1 Derived Immunogens in Infected Individuals With >= 500 CD4 Cells/mm3 medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like A Phase I Comparative Blinded Trial of Several HIV-1 Derived Immunogens in Infected Individuals With >= 500 CD4 Cells/mm3. A Phase I Comparative Blinded Trial of Several HIV-1 Derived Immunogens in Infected Individuals With >= 500 CD4 Cells/mm3 Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a A Phase I Comparative Blinded Trial of Several HIV-1 Derived Immunogens in Infected Individuals With >= 500 CD4 Cells/mm3 clinical trial. Subjects typically recieve the finest healthcare available for their A Phase I Comparative Blinded Trial of Several HIV-1 Derived Immunogens in Infected Individuals With >= 500 CD4 Cells/mm3 condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Phase I Comparative Blinded Trial of Several HIV-1 Derived Immunogens in Infected Individuals With >= 500 CD4 Cells/mm3  A Phase I Comparative Blinded Trial of Several HIV-1 Derived Immunogens in Infected Individuals With >= 500 CD4 Cells/mm3
A Phase I Comparative Blinded Trial of Several HIV-1 Derived Immunogens in Infected Individuals With >= 500 CD4 Cells/mm3
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: PRIMARY: To compare the immunogenicity and safety of each of several HIV-1 derived immunogens versus control in HIV-infected individuals with CD4 counts greater than or equal to 500 cells/mm3. SECONDARY: To determine whether significant advantages to any one vaccine exist. Before large clinical trials of anti-HIV vaccines are undertaken, it is important to determine whether there are significant advantages to any one of the vaccines currently offered for such studies.
Details: Before large clinical trials of anti-HIV vaccines are undertaken, it is important to determine whether there are significant advantages to any one of the vaccines currently offered for such studies. Patients are randomized to receive one of four vaccines or one of two placebo controls. The vaccines are: rgp 120/HIV-1IIIB, rgp 120/HIV-1MN, rgp 120/HIV-1SF, and env 2-3. The two control immunogens are aluminum hydroxide (alum) and BIOCINE Placebo Vaccine 2 (MF-59 adjuvant emulsion in citrate buffer). Patients are vaccinated at weeks 0, 4, 8, 12, 16, 20, 28, and 36. If significant benefit is seen among vaccine patients, then placebo patients may receive vaccination with one of the immunogens producing an immune response.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Short-term nonsteroidal anti-inflammatory therapy. Patients must have: - HIV seropositivity. - CD4 count >= 500 cells/mm3. - Successful establishment of EBV-transformed B-cell lines at study entry. - Consent of parent or guardian if < 18 years of age. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Suspected or known allergies to any vaccine components. - Medical contraindication. - Problem with compliance. Concurrent Medication: Excluded: - Antiretroviral therapy (e.g., AZT, ddI, or ddC). - Agents with putative immunomodulating activity (e.g., interferon, steroids, hematopoietin). - Parenteral therapies (including SC allergy sensitization). - Other investigational HIV drugs or therapies. Prior Medication: Excluded: - Any prior vaccinations against HIV. - Antiretroviral therapy (e.g., AZT, ddI, or ddC) within the past 6 months. - Agents with putative immunomodulating activity (e.g., interferon, steroids, hematopoietin) within the past 3 months. - Parenteral therapies (including SC allergy sensitization) within the past 3 months. - Other investigational HIV drugs or therapies within the past 3 months.
Total Enrollment: 130
Location and Contact Information:
Overall Study Official:
SchooleyRT, Study Chair,
Boston Med Ctr
Boston, Massachusetts, 02118
United States
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
Newark, New Jersey, 071072198
United States
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose, California, 951282699
United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
United States
Stanford Univ Med Ctr
Stanford, California, 943055107
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, 94115
United States
Univ of Washington
Seattle, Washington, 981224304
United States
San Mateo AIDS Program / Stanford Univ
Stanford, California, 943055107
United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
Yale Univ / New Haven
New Haven, Connecticut, 065102483
United States
Additional Information:
Study ID Numbers: ACTG 214;
Study Start Date:
Record last reviewed: October 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000779
Other Hiv Infections Studies:
1. Treatment with Combinations of Several Antiviral Drugs in Infants and Young Children with HIV Infection
2. A Multicenter, Randomized, Placebo-Controlled, Double-Blinded, Phase I Trial to Evaluate the Safety and Immunogenicity of Live Recombinant Canarypox ALVAC-HIV vCP205 Combined with GM-CSF in Healthy, HIV-1 Uninfected Volunteers
3. A Phase I Study of AZT and Human Interferon Alpha (Recombinant Alpha-2A and Lymphoblastoid) in the Treatment of AIDS-Associated Kaposi's Sarcoma
4. A Study of Valganciclovir in the Treatment of Cytomegalovirus (CMV) Retinitis in Patients with AIDS
5. Viracept Expanded Access Program
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A Phase I Comparative Blinded Trial of Several HIV-1 Derived Immunogens in Infected Individuals With >= 500 CD4 Cells/mm3
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