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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 Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. 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 healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including 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 volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes 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. Participants typically obtain the most effective 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. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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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. A Randomized, Placebo-Controlled, Double-Blinded Phase I Safety and Immunogenicity Trial of Recombinant Envelope Protein, HIV-1 SF-2 rgp120 (BIOCINE), Combined with MF59 in HIV-1 Uninfected Adult Volunteers
2. A Treatment Protocol for the Use of Intravenous Ganciclovir in AIDS Patients With Immediately Sight-Threatening CMV Retinitis
3. The Safety and Effectiveness of Human Monoclonal Antibody, F105, in the Treatment of HIV
4. A Study of Saquinavir Soft Gel Capsules (SGC) Used in Combination With Two Other Anti-HIV Drugs in Patients with HIV-Associated Kidney Disease
5. A Study of Capravirine Plus VIRACEPT Plus Two Nucleoside Reverse Transcriptase Inhibitors in HIV-Infected Patients Who Failed Previous Anti-HIV Treatments
Related Studies:
Other HIV Infections Clinical Trials
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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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