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A Phase I/II Trial of Vaccine Therapy of HIV-1 Infected Individuals With 50-500 CD4 Cells/mm3 Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about A Phase I/II Trial of Vaccine Therapy of HIV-1 Infected Individuals With 50-500 CD4 Cells/mm3 conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Phase I/II Trial of Vaccine Therapy of HIV-1 Infected Individuals With 50-500 CD4 Cells/mm3 Clinical research trials and A Phase I/II Trial of Vaccine Therapy of HIV-1 Infected Individuals With 50-500 CD4 Cells/mm3 medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as A Phase I/II Trial of Vaccine Therapy of HIV-1 Infected Individuals With 50-500 CD4 Cells/mm3. A Phase I/II Trial of Vaccine Therapy of HIV-1 Infected Individuals With 50-500 CD4 Cells/mm3 Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a A Phase I/II Trial of Vaccine Therapy of HIV-1 Infected Individuals With 50-500 CD4 Cells/mm3 clinical trial. Participants frequently get the best healthcare available for their A Phase I/II Trial of Vaccine Therapy of HIV-1 Infected Individuals With 50-500 CD4 Cells/mm3 condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Phase I/II Trial of Vaccine Therapy of HIV-1 Infected Individuals With 50-500 CD4 Cells/mm3  A Phase I/II Trial of Vaccine Therapy of HIV-1 Infected Individuals With 50-500 CD4 Cells/mm3
A Phase I/II Trial of Vaccine Therapy of HIV-1 Infected Individuals With 50-500 CD4 Cells/mm3
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Genentech,Glaxo Wellcome
Synopsis: To examine the response of HIV-1 infected patients to vaccination with gp120/HIV-1MN antigen. To determine the effect of antiretroviral therapy on vaccine responsiveness. Fifty percent of HIV-1 infected individuals remain symptom free for 8-12 years. It has been hypothesized that HIV-specific immune responses are responsible for the period of relative quiescence of viral replication. Recent studies suggest that these immune functions can be augmented by vaccination with HIV-derived antigens.
Details: Fifty percent of HIV-1 infected individuals remain symptom free for 8-12 years. It has been hypothesized that HIV-specific immune responses are responsible for the period of relative quiescence of viral replication. Recent studies suggest that these immune functions can be augmented by vaccination with HIV-derived antigens. Patients are randomized to receive rgp120/HIV-1MN vaccine or alum adjuvant placebo by intramuscular injection at weeks 0, 4, 8, 12, 16, and 20, with or without daily oral zidovudine (AZT) or their current stable dose of antiretroviral therapy. After completing the primary vaccination series, patients are permitted to continue into an extension phase, in which they receive a booster vaccination at weeks 28, 36, and 44. Patients will be stratified by CD4 count: 350-500, 200-349, and 50-199 cells/mm3. A fourth group with counts of 350-500 cells/mm3 will serve as a pilot group and receive vaccine only.
Eligibility:
Study Type: Interventional, Prevention, Parallel Assignment
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Required immediately prior to study entry: - A minimum of 2 and a maximum of 12 months of AZT therapy at 500-600 mg/day (does not apply to the pilot group patients receiving vaccine only and to patients with CD4 counts of 50-199 cells/mm3). Concurrent Medication: Allowed: - PCP prophylaxis. - Rifabutin and clarithromycin (in patients with CD4 counts of 50-199 cells/mm3 only). - Short-term nonsteroidal anti-inflammatory therapy for acute conditions. - Short intermittent cycles of acyclovir. Patients must have: - HIV infection, with CD4 count of 50-500 cells/mm3. - No active opportunistic infection (patients with CD4 counts of 50-199 cells/mm3 may have a history of an opportunistic infection). - Consent of parent, guardian, or person with power of attorney, if less than 18 years of age. - B-cell lines established in order to be vaccinated. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Known or suspected allergies to any vaccine components. Concurrent Medication: Excluded: - Agents with immunosuppressive activity. - Antiretroviral therapies other than AZT (except in patients with CD4 counts of 50-199 cells/mm3). - Interferon. - Parenteral therapies (including SC allergy medications and chemotherapy for Kaposi's sarcoma). - Steroids. - Hematopoietins. Prior Medication: Excluded within 12 weeks prior to study entry: - Agents with immunosuppressive activity. - Antiretroviral therapies other than AZT (except in patients with CD4 counts of 50-349 cells/mm3). - Interferon. - Parenteral therapies (including SC allergy medications and chemotherapy for Kaposi's sarcoma). - Steroids. - Hematopoietins. Active drug abuse.
Total Enrollment: 168
Location and Contact Information:
Overall Study Official:
SchooleyRT, Study Chair,
Yale Univ / New Haven
New Haven, Connecticut, 065102483
United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Boston Med Ctr
Boston, Massachusetts, 02118
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215
United States
Stanford Univ Med Ctr
Stanford, California, 943055107
United States
Yale Univ
New Haven, Connecticut, 06519
United States
AIDS Clinical Research Ctr / UCLA Med Ctr
Los Angeles, California, 900951793
United States
Univ of Washington
Seattle, Washington, 981224304
United States
Additional Information:
Study ID Numbers: ACTG 209;
Study Start Date:
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000755
Other Hiv Infections Studies:
1. The Antiviral Efficacy of Concurrent Zidovudine and 2',3'-dideoxyinosine or 2',3'-dideoxycytidine in Patients with Human Immunodeficiency Virus Disease
2. A Study to Compare the Use of Fluconazole as Continuous Therapy Versus Periodic Therapy in HIV-Positive Patients with Recurrent Thrush
3. Continuous High-Dose Intravenous Dextran Sulfate in Human Immunodeficiency Virus-Infected Individuals
4. A Pilot Study to Obtain Preliminary Information Regarding the Efficacy and Safety of the Combination of Immune Globulin and Ganciclovir as Compared to Ganciclovir Alone in the Treatment of Sight-Threatening CMV Retinitis in Patients With AIDS
5. Phase I Safety and Immunogenicity Trial of Vaccinia-HIV Envelope Recombinant Vaccine (HIVAC-1e) in Combination with Soluble Recombinant Envelope Vaccine (gp160; VaxSyn)
Related Studies:
Other HIV Infections Clinical Trials
Other Massachusetts Clinical Trials
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A Phase I/II Trial of Vaccine Therapy of HIV-1 Infected Individuals With 50-500 CD4 Cells/mm3
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