Delayed-type hypersensitivity to recombinant HIV envelope glycoprotein (rgp160) after immunization with homologous antigen.
D A Katzenstein, S Kundu, J Spritzler...
https://pubmed.ncbi.nlm.nih.gov/10634195Completed
Phase 1
Age: 18Years +
All Genders
ID00000977
Active Immunization of Asymptomatic, HIV-Infected Individuals With Recombinant GP160 HIV-1 Antigen: A Phase I/II Study of Immunogenicity and Toxicity
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-11-04
52
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
N
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
P
Protein Sciences Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Active Immunization of Asymptomatic, HIV-Infected Individuals With Recombinant GP160 HIV-1 Antigen: A Phase I/II Study of Immunogenicity and Toxicity
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
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).
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 2 locations
1
Stanford CRS
Palo Alto, California, United States, 94305
Status Unknown
2
NY Univ. HIV/AIDS CRS
New York, New York, United States, 10016
Status Unknown
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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Published Research Related To This Trial
Effect of therapeutic immunization with recombinant gp160 HIV-1 vaccine on HIV-1 proviral DNA and plasma RNA: relationship to cellular immune responses.
S K Kundu, D Katzenstein, F T Valentine...
https://pubmed.ncbi.nlm.nih.gov/9292585A randomized, placebo-controlled study of the immunogenicity of human immunodeficiency virus (HIV) rgp160 vaccine in HIV-infected subjects with > or = 400/mm3 CD4 T lymphocytes (AIDS Clinical Trials Group Protocol 137).
F T Valentine, S Kundu, P A Haslett...
https://pubmed.ncbi.nlm.nih.gov/8648205Enhancement of human immunodeficiency virus (HIV)-specific CD4+ and CD8+ cytotoxic T-lymphocyte activities in HIV-infected asymptomatic patients given recombinant gp160 vaccine.
S K Kundu, D Katzenstein, L E Moses...
https://pubmed.ncbi.nlm.nih.gov/1360665