Completed

A Phase I/II Study of Delayed-Type Hypersensitivity (DTH) Reactions to Intradermal HIV Envelope Antigen

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What is being tested

gp160 Vaccine (Immuno-AG)

+ gp160 Vaccine (MicroGeneSys)
Biological
Who is being recruted

HIV Infections

Over 18 Years
How is the trial designed

Treatment Study

Phase 1
Interventional

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 4, 2021
Sourced from a government-validated database.Claim as a partner

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. 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.

Official TitleA Phase I/II Study of Delayed-Type Hypersensitivity (DTH) Reactions to Intradermal HIV Envelope Antigen 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 4, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
50 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label
: Everyone knows which treatment is being given.

Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
HIV Infections
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.



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 4 locations
Suspended
Stanford CRSPalo Alto, United StatesSee the location
Suspended
Santa Clara Valley Med. Ctr.San Jose, United States
Suspended
San Mateo County AIDS ProgramSan Mateo, United States
Suspended
NY Univ. HIV/AIDS CRSNew York, United States

Completed4 Study Centers