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A Phase I/II Double-Blind Controlled Trial to Determine the Safety and Immunogenicity of HIV-1 MN rgp160 Immuno AG Vaccine Therapy in HIV-Infected Individuals with Greater than or Equal to 500/mm3 CD4+ T Cells and 200-400/mm3 CD4+ T Cells Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on A Phase I/II Double-Blind Controlled Trial to Determine the Safety and Immunogenicity of HIV-1 MN rgp160 Immuno AG Vaccine Therapy in HIV-Infected Individuals with Greater than or Equal to 500/mm3 CD4+ T Cells and 200-400/mm3 CD4+ T Cells conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Phase I/II Double-Blind Controlled Trial to Determine the Safety and Immunogenicity of HIV-1 MN rgp160 Immuno AG Vaccine Therapy in HIV-Infected Individuals with Greater than or Equal to 500/mm3 CD4+ T Cells and 200-400/mm3 CD4+ T Cells Clinical research trials and A Phase I/II Double-Blind Controlled Trial to Determine the Safety and Immunogenicity of HIV-1 MN rgp160 Immuno AG Vaccine Therapy in HIV-Infected Individuals with Greater than or Equal to 500/mm3 CD4+ T Cells and 200-400/mm3 CD4+ T Cells healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like A Phase I/II Double-Blind Controlled Trial to Determine the Safety and Immunogenicity of HIV-1 MN rgp160 Immuno AG Vaccine Therapy in HIV-Infected Individuals with Greater than or Equal to 500/mm3 CD4+ T Cells and 200-400/mm3 CD4+ T Cells. A Phase I/II Double-Blind Controlled Trial to Determine the Safety and Immunogenicity of HIV-1 MN rgp160 Immuno AG Vaccine Therapy in HIV-Infected Individuals with Greater than or Equal to 500/mm3 CD4+ T Cells and 200-400/mm3 CD4+ T Cells Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a A Phase I/II Double-Blind Controlled Trial to Determine the Safety and Immunogenicity of HIV-1 MN rgp160 Immuno AG Vaccine Therapy in HIV-Infected Individuals with Greater than or Equal to 500/mm3 CD4+ T Cells and 200-400/mm3 CD4+ T Cells clinical trial. Human subjects often obtain the finest healthcare possible for their A Phase I/II Double-Blind Controlled Trial to Determine the Safety and Immunogenicity of HIV-1 MN rgp160 Immuno AG Vaccine Therapy in HIV-Infected Individuals with Greater than or Equal to 500/mm3 CD4+ T Cells and 200-400/mm3 CD4+ T Cells condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Phase I/II Double-Blind Controlled Trial to Determine the Safety and Immunogenicity of HIV-1 MN rgp160 Immuno AG Vaccine Therapy in HIV-Infected Individuals with Greater than or Equal to 500/mm3 CD4+ T Cells and 200-400/mm3 CD4+ T Cells  A Phase I/II Double-Blind Controlled Trial to Determine the Safety and Immunogenicity of HIV-1 MN rgp160 Immuno AG Vaccine Therapy in HIV-Infected Individuals with Greater than or Equal to 500/mm3 CD4+ T Cells and 200-400/mm3 CD4+ T Cells
A Phase I/II Double-Blind Controlled Trial to Determine the Safety and Immunogenicity of HIV-1 MN rgp160 Immuno AG Vaccine Therapy in HIV-Infected Individuals with Greater than or Equal to 500/mm3 CD4+ T Cells and 200-400/mm3 CD4+ T Cells
For Condition: HIV Infections
Status: Completed
Sponsor(s): Immuno-US , National Institute of Allergy and Infectious Diseases (NIAID),Bristol-Myers Squibb
Synopsis: To evaluate the safety and immunogenicity of HIV-1 MN rgp160 (Immuno-AG) in HIV-infected patients. To evaluate the immunogenicity of HIV-1 MN rgp160 immunogen by lymphocyte proliferation, specific antibody responses, and DTH reaction. To describe the durability of the immunogen in patients who respond to the first 7 injections when they are boosted every 8 weeks for an additional 6-12 months [AS PER AMENDMENT 11/12/96: stratum 1 patients only]. To describe the ability of the immunogen to induce a response after an additional 6-12 months of injections among patients who did not respond to the first 7 injections [AS PER AMENDMENT 11/12/96: stratum 1 patients only]. HIV-specific cellular immune responses appear to play an important role in HIV disease progression since both T helper and cytotoxic function against HIV decrease with disease progression.
Details: HIV-specific cellular immune responses appear to play an important role in HIV disease progression since both T helper and cytotoxic function against HIV decrease with disease progression. Patients with CD4 counts greater than or equal to 500 cells/mm3 are randomized to receive HIV-1 MN rgp160 (Immuno-AG) or control. Patients with CD4 counts 50-499 cells/mm3 receive didanosine (ddI) and are then randomized to receive ddI plus vaccine or control. Vaccine or control is given every 4 weeks for 7 injections, then every 8 weeks for 6-12 months or until 1 year after the last patient is randomized. AS PER AMENDMENT 11/12/96: Stratum 1 is composed of 16 subjects with CD4+ T cells greater than or equal to 500 mm3. These subjects are randomized to vaccine therapy or vaccine control. HIV-1 MN rgp160 vaccine or control is given every 4 weeks for 7 injections (Schedule 1), then every 8 weeks until 52 weeks after the last subject has been randomized to stratum 1 (Schedule 2). Stratum 1 patients receive ddI or d4T only if their CD4 cell count has a sustained decrease on 2 consecutive occasions 10-14 days apart and/or HIV/RNA plasma viral load increases to greater than 10,000 copies/ml on 2 consecutive occasions 10-14 days apart. Stratum 2 is composed of 30 subjects with CD4+ T cells 200-400/mm3; accrual to this stratum was activated based on preliminary results from stratum 1 (closed as of 4/5/97). Patients on stratum 2 (open as of 3/4/97) initially receive ritonavir at escalating doses for 2 weeks. Subjects then have ddI and d4T added to the regimen for 7 weeks. Subjects are then randomized to vaccine therapy or vaccine control every 4 weeks for 7 injections, with ritonavir/ddI/d4T continued during vaccine therapy. AS PER AMENDMENT 3/23/98: As of 6/1/98 vaccine consists of sodium chloride for injection (USP).
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - ddI [AS PER AMENDMENT 11/12/96: and d4T]. (Note: - Patients in the stratum receiving only vaccine or control may take ddI [AS PER AMENDMENT 11/12/96: - and d4T] ONLY IF their CD4 counts have shown a sustained decrease on two consecutive occasions 10-14 days apart.) - PCP prophylaxis. - Treatment for acute conditions, as indicated. AS PER AMENDMENT 11/12/96: - Co-enrollment on other research trials. Patients must have: - HIV positivity. - Asymptomatic disease. - CD4 count >= 50 cells/mm3 (CD4 count must be 50-499 cells/mm3 in patients receiving ddI plus vaccine or control, and must be >= 500 cells/mm3 in patients receiving vaccine or control only) [AS PER AMENDMENT 11/12/96: - CD4 count >= 500 cells/mm3 for stratum 1 patients and 200-400 for stratum 2 patients]. - HLA A2 positive documentation. - An Epstein Barr virus B cell line established within 90 days prior to study entry. - Consent of parent or guardian if less than 18 years of age. NOTE: - Study is NOT approved for prisoner participation. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Medical contraindication to study participation or inability to comply with study requirements. - Grade 2 or worse peripheral neuropathy (applicable only to patients receiving ddI plus vaccine or control). Concurrent Medication: Excluded: - Immunomodulating agents, such as inosiplex, ditiocarb sodium, lithium, interferons, interleukin-2, and systemic steroids. - Any antiretroviral therapy that may increase the risk of peripheral neuropathy (e.g., stavudine, zalcitabine [AS PER AMENDMENT 11/12/96: - e.g., zalcitabine or lamivudine]). - Agents such as IV pentamidine that may increase the risk of pancreatitis. - Standard of care vaccines (in patients receiving vaccine) [AS PER AMENDMENT 11/12/96: - Standard of care immunizations are permitted 60 days before Schedule 1 vaccine therapy and during Schedule 2 vaccine therapy (but not within 2 weeks of study immunization)]. AS PER AMENDMENT 11/12/96: - Rifabutin, disulfiram (antabuse), or other medication with similar effects, including metronidazole. 6.AS PER AMENDMENT 11/12/96: - The following are prohibited in patients receiving ritonavir: - amiodarone, astemizole, bepridil, bupropion, cisapride, clozapine, encainide, flecainide, meperidine, piroxicam, propafenone, propoxyphene, quinidine, rifabutin, terfenadine, alprazolam, clorazepate, diazepam, estazolam, flurazepam, midazolam, triazolam, and zolpidem. Patients with the following prior conditions are excluded: - History of grade 2 or worse liver abnormality. - Known allergy to vaccine components. - Chronic diarrhea persisting for 4 or more weeks within 30 days prior to study entry. - History of pancreatitis (applicable only to patients receiving ddI plus vaccine or control). [AS PER AMENDMENT 11/12/96: - History of chronic pancreatitis or history of acute pancreatitis within 2 years prior to entry (stratum 2 patients only).] Prior Medication: Excluded: - Any prior anti-HIV vaccines. Excluded within 90 days prior to study entry: - Immunomodulating agents, such as Inosiplex, ditiocarb sodium, lithium, interferons, interleukin-2, and systemic steroids. - Any antiretroviral therapy that may increase the risk of peripheral neuropathy (e.g., stavudine, zalcitabine [AS PER AMENDMENT 11/12/96: - e.g., zalcitabine or lamivudine]). - Agents such as IV pentamidine that may increase the risk of pancreatitis. - Any treatment for an AIDS-defining illness (applicable ONLY to patients in the stratum receiving ddI plus vaccine or control). Excluded within 6 months prior to study entry: - Any other antiretrovirals or immunomodulators besides those mentioned above. - Allergy desensitization or other vaccines [AS PER AMENDMENT 11/12/96: - excluded within 60 days prior to entry].
Total Enrollment: 16
Location and Contact Information:
Overall Study Official:
KunduSmriti, Study Chair,
Univ of Texas Galveston
Galveston, Texas, 775550435
United States
Stanford Univ Med Ctr
Stanford, California, 943055107
United States
Additional Information:
Study ID Numbers: ACTG 246/946;
Study Start Date:
Record last reviewed: October 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000822
Other Hiv Infections Studies:
1. Acetyl-L-Carnitine for the Treatment of NRTI-Associated Peripheral Neuropathy
2. Antibiotics to Reduce Chorioamnionitis-Related Perinatal HIV Transmission
3. Comparison of New Anti-HIV Drug Combinations in HIV-Infected Children Who Have Taken Anti-HIV Drugs
4. Zidovudine Levels in HIV Infected Patients Being Treated for HCV
5. Tuberculosis in a Multiethnic Inner City Population
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A Phase I/II Double-Blind Controlled Trial to Determine the Safety and Immunogenicity of HIV-1 MN rgp160 Immuno AG Vaccine Therapy in HIV-Infected Individuals with Greater than or Equal to 500/mm3 CD4+ T Cells and 200-400/mm3 CD4+ T Cells
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