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A Phase I/II Study of Delayed-Type Hypersensitivity (DTH) Reactions to Intradermal HIV Envelope Antigen Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about A Phase I/II Study of Delayed-Type Hypersensitivity (DTH) Reactions to Intradermal HIV Envelope Antigen conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Phase I/II Study of Delayed-Type Hypersensitivity (DTH) Reactions to Intradermal HIV Envelope Antigen Clinical research trials and A Phase I/II Study of Delayed-Type Hypersensitivity (DTH) Reactions to Intradermal HIV Envelope Antigen health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including A Phase I/II Study of Delayed-Type Hypersensitivity (DTH) Reactions to Intradermal HIV Envelope Antigen. A Phase I/II Study of Delayed-Type Hypersensitivity (DTH) Reactions to Intradermal HIV Envelope Antigen Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a A Phase I/II Study of Delayed-Type Hypersensitivity (DTH) Reactions to Intradermal HIV Envelope Antigen clinical trial. Human subjects often get the best healthcare possible for their A Phase I/II Study of Delayed-Type Hypersensitivity (DTH) Reactions to Intradermal HIV Envelope Antigen condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Phase I/II Study of Delayed-Type Hypersensitivity (DTH) Reactions to Intradermal HIV Envelope Antigen  A Phase I/II Study of Delayed-Type Hypersensitivity (DTH) Reactions to Intradermal HIV Envelope Antigen
A Phase I/II Study of Delayed-Type Hypersensitivity (DTH) Reactions to Intradermal HIV Envelope Antigen
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To determine the frequency of delayed-type hypersensitivity (DTH) reactions in HIV-positive patients to two doses of two envelope glycoprotein antigens prepared differently. To determine whether patients who have previously demonstrated a DTH response to intradermal MGStage HIV-1 gp160 IIIB baculovirus (MicroGeneSys) have a reproducible response to a repeat injection of gp160 and whether there is cross-reactivity to intradermal HIV-1 rgp160 IIIB vero cell expressed (Immuno-AG). PER 4/5/95 AMENDMENT: To also determine whether patients who respond to HIV-1 rgp160 IIIB baculovirus (MicroGeneSys) have cross-reactivity to intradermal skin tests of HIV-1 rgp160 MN (Immuno-AG). Previous studies in individuals immunized with gp160 suggest that a skin test response in immunized patients can be used as a surrogate marker for new proliferative and cytotoxic responses induced by vaccination.
Details: Previous studies in individuals immunized with gp160 suggest that a skin test response in immunized patients can be used as a surrogate marker for new proliferative and cytotoxic responses induced by vaccination. Patients are stratified into three groups. Fifteen patients previously immunized with MicroGeneSys rgp160 antigen in ACTG 137 and not on antiretroviral therapy will receive intradermal injections of Immuno-AG rgp160 IIIB (vero cell expressed) in one arm, followed 1 week later by intradermal injections of MicroGeneSys rgp160 IIIB (baculovirus expressed) in the opposite arm (stratum 1). Forty patients who are not previously immunized with rgp160 will receive intradermal injections of Immuno-AG gp160 IIIB in one arm simultaneously with MicroGeneSys gp160 IIIB in the opposite arm; these patients are either not on antiretroviral therapy (stratum 2) or currently on antiretroviral therapy (stratum 3). All patients return 48 hours after each injection for skin test reading. PER 4/5/95 AMENDMENT: Patients on all strata will re-enroll to receive Immuno-AG rgp160 MN in one arm simultaneously with MicroGeneSys rgp160 IIIB in the opposite arm.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed in Step 2 (PER 4/5/95 AMENDMENT): - Approved antiretroviral drugs. Patients must have: - Documented HIV infection. - CD4 count >= 400 cells/mm3. - NO current active opportunistic infection or neoplasm (other than stable cutaneous Kaposi's sarcoma). Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Known hypersensitivity to insect proteins. Concurrent Medication: Excluded: - Antihistamine or anti-inflammatory medications for the 48-hour period between injection and skin test reading. - Topical steroids. Prior Medication: PER 4/5/95 AMENDMENT - Excluded: - Prior immunization with experimental HIV vaccines (strata 2 and 3 only). - Systemic corticosteroids, topical corticosteroids on the arms, or other systemic immunosuppressant agents or antineoplastic agents within 30 days prior to study entry. - Antihistamine or anti-inflammatory medications within 72 hours prior to intradermal injections. PREVIOUS VERSION - Excluded within 30 days prior to study entry: - Any antiretroviral drugs (other than AZT, ddI, ddC, or d4T for patients in stratum 3). - Systemic corticosteroids, topical corticosteroids on the arms, or other systemic immunosuppressant agents or antineoplastic agents. Excluded within 72 hours prior to intradermal injections: - Antihistamine or anti-inflammatory medications.
Total Enrollment: 50
Location and Contact Information:
Overall Study Official:
KatzensteinD, Study Chair,
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
San Mateo AIDS Program / Stanford Univ
Stanford, California, 943055107
United States
Stanford Univ Med Ctr
Stanford, California, 943055107
United States
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose, California, 951282699
United States
Additional Information:
Study ID Numbers: ACTG 221;
Study Start Date:
Record last reviewed: October 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000782
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A Phase I/II Study of Delayed-Type Hypersensitivity (DTH) Reactions to Intradermal HIV Envelope Antigen
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