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Active Immunization of Asymptomatic, HIV-Infected Individuals With Recombinant GP160 HIV-1 Antigen: A Phase I/II Study of Immunogenicity and Toxicity 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 Active Immunization of Asymptomatic, HIV-Infected Individuals With Recombinant GP160 HIV-1 Antigen: A Phase I/II Study of Immunogenicity and Toxicity conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Active Immunization of Asymptomatic, HIV-Infected Individuals With Recombinant GP160 HIV-1 Antigen: A Phase I/II Study of Immunogenicity and Toxicity Clinical research trials and Active Immunization of Asymptomatic, HIV-Infected Individuals With Recombinant GP160 HIV-1 Antigen: A Phase I/II Study of Immunogenicity and Toxicity 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 Active Immunization of Asymptomatic, HIV-Infected Individuals With Recombinant GP160 HIV-1 Antigen: A Phase I/II Study of Immunogenicity and Toxicity. Active Immunization of Asymptomatic, HIV-Infected Individuals With Recombinant GP160 HIV-1 Antigen: A Phase I/II Study of Immunogenicity and Toxicity 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 Active Immunization of Asymptomatic, HIV-Infected Individuals With Recombinant GP160 HIV-1 Antigen: A Phase I/II Study of Immunogenicity and Toxicity clinical trial. Participants typically obtain the most effective healthcare available for their Active Immunization of Asymptomatic, HIV-Infected Individuals With Recombinant GP160 HIV-1 Antigen: A Phase I/II Study of Immunogenicity and Toxicity 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 > Active Immunization of Asymptomatic, HIV-Infected Individuals With Recombinant GP160 HIV-1 Antigen: A Phase I/II Study of Immunogenicity and Toxicity  Active Immunization of Asymptomatic, HIV-Infected Individuals With Recombinant GP160 HIV-1 Antigen: A Phase I/II Study of Immunogenicity and Toxicity
Active Immunization of Asymptomatic, HIV-Infected Individuals With Recombinant GP160 HIV-1 Antigen: A Phase I/II Study of Immunogenicity and Toxicity
For Condition: HIV Infections
Status: Completed
Sponsor(s): MicroGeneSys , National Institute of Allergy and Infectious Diseases (NIAID)
Synopsis: To determine the minimal effective (immunogenic) dose of vaccine in asymptomatic HIV-1 seropositive individuals with > 400 cells/mm3 (CD4). To determine the dose-response to a 4 fold escalation of the immunizing dose. To describe both cellular and humoral immune responses to HIV-1 in the immunized individuals. To describe the effects of this immunization on general immunological, virological and clinical parameters. To evaluate the safety of injecting recombinant gp160 in this population. To evaluate the extent of variability between different lots of gp160 (arms C1 and C2). It might be possible to increase immune responses or to induce new types of immune responses to HIV in some infected individuals by means of a vaccine, which could result in an immunological, virological or clinical benefit.
Details: It might be possible to increase immune responses or to induce new types of immune responses to HIV in some infected individuals by means of a vaccine, which could result in an immunological, virological or clinical benefit. ORIGINAL DESIGN: Patients are randomized to one of five groups to receive, intramuscularly, one of four dosages of gp160 or hepatitis B vaccine as a control. Treatments are given at 0, 1, 3, 6, 9, and 12 months and patients are followed for up to 2 years. Patients in any of the 5 groups will have the option of switching to another dosage group if an interim analysis at 6 months shows significant differences in patient response. AMENDED: 10/23/90 52 eligible patients are randomized to one of 6 study groups. Five groups of 8 individuals receive one of 4 dosage levels of gp160 (Groups A, B, C1, C2, and D), and 12 patients receive a single dosage level of hepatitis B vaccine as a control (Group E). Per 2/19/92 amendment, patients may elect to continue receiving vaccine beyond 12 months, with the doses given either every 3 months or every 6 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Acute use (< 14 days) of acyclovir for Herpes simplex virus infection or ketoconazole for symptomatic Candida infections. An additional group of up to 20 patients may be added to the study. Patients from ACTG 148 with a repeatedly negative delayed-type hypersensitivity (DTH) reaction who have reached their third dose of ID gp160 at 32 mcg and have failed to develop new proliferative response have the option, after a 2-month interval, to enter this protocol. - They must meet inclusion and exclusion criteria that apply to this protocol. - Patients with CD4 counts of 400 - 500 cells/mm3 must be informed of the recommended zidovudine (AZT) therapy and sign an informed consent statement declining AZT therapy. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: - Fever of > 100 degrees F persisting for > 15 days in a 30-day interval without definable cause. - Recurrent oral candidiasis. - Multidermatomal herpes zoster. - Biopsy-proven hairy leukoplakia. - Fatigue/malaise of > 1 month duration that interferes with normal activities. - Evidence of clinically significant central nervous system dysfunction as assessed by neurological exam. - Involuntary weight loss > 10 lbs or 10 percent of normal weight in a 6 month interval. - Diarrhea (> 3 stools/day) for more than 30 days without definable cause. Concurrent Medication: Excluded: - Antiretroviral agents of proven or potential efficacy or any potential immunoenhancing or immunosuppressive drugs. Patients with the following are excluded: - Known hypersensitivity to insect cells or baculovirus. - Abnormal chest x-ray taken within 3 months of study entry. - Systemic symptoms thought to be due to HIV infection (other than lymphadenopathy). Evidence of clinically significant central nervous system dysfunction as assessed by neurological exam. - Unwilling or unable to give written informed consent. Prior Medication: Excluded within 90 days of study entry: - Zidovudine (AZT), didanosine (ddI), or any potential antiretroviral or immunomodulating agents. Active substance abuse (either continuing daily alcohol abuse or intravenous drug use).
Total Enrollment: 52
Location and Contact Information:
Overall Study Official:
ValentineF, Study Chair,
Stanford Univ School of Medicine
Stanford, California, 94305
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Additional Information:
Study ID Numbers: ACTG 137;
Study Start Date:
Record last reviewed: October 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000977
Other Hiv Infections Studies:
1. An Open Label Phase I Study of Subcutaneously Administered Recombinant Human GM-CSF in Patients with AIDS Virus Infection and Leukopenia
2. A Comparison of Saquinavir Hard- and Soft-Gelatin Capsules in HIV-Infected Patients
3. Comparison of Brovavir Versus Acyclovir in the Treatment of Herpes in HIV-Infected Patients
4. The Safety and Effectiveness of FIAC in the Treatment of Cytomegalovirus (CMV) in Patients with AIDS
5. A Prospective Double-Blind Study of Retrovir in Early HIV Infection
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Active Immunization of Asymptomatic, HIV-Infected Individuals With Recombinant GP160 HIV-1 Antigen: A Phase I/II Study of Immunogenicity and Toxicity
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