Active Immunization of Asymptomatic, HIV-Infected Individuals With Recombinant GP160 HIV-1 Antigen: A Phase I/II Study of Immunogenicity and Toxicity
NCT ID: NCT00000977
Last Updated: 2021-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
52 participants
INTERVENTIONAL
1993-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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gp160 Vaccine (MicroGeneSys)
Eligibility Criteria
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Inclusion Criteria
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.
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).
18 Years
ALL
No
Sponsors
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Protein Sciences Corporation
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Valentine F
Role: STUDY_CHAIR
Locations
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Stanford CRS
Palo Alto, California, United States
NY Univ. HIV/AIDS CRS
New York, New York, United States
Countries
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References
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Katzenstein DA, Kundu S, Spritzler J, Smoller BR, Haszlett P, Valentine F, Merigan TC. Delayed-type hypersensitivity to recombinant HIV envelope glycoprotein (rgp160) after immunization with homologous antigen. J Acquir Immune Defic Syndr. 1999 Dec 1;22(4):341-7. doi: 10.1097/00126334-199912010-00004.
Kundu SK, Katzenstein D, Valentine FT, Spino C, Efron B, Merigan TC. Effect of therapeutic immunization with recombinant gp160 HIV-1 vaccine on HIV-1 proviral DNA and plasma RNA: relationship to cellular immune responses. J Acquir Immune Defic Syndr Hum Retrovirol. 1997 Aug 1;15(4):269-74. doi: 10.1097/00042560-199708010-00004.
Valentine F, et al. A randomized, controlled study of immunogenicity of rgp160 vaccine in HIV-infected subjects. Int Conf AIDS. 1992 Jul 19-24;8(1):Tu39 (abstract no TuB 0561)
Valentine FT, Kundu S, Haslett PA, Katzenstein D, Beckett L, Spino C, Borucki M, Vasquez M, Smith G, Korvick J, Kagan J, Merigan TC. A 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). J Infect Dis. 1996 Jun;173(6):1336-46. doi: 10.1093/infdis/173.6.1336.
Kundu SK, Katzenstein D, Moses LE, Merigan TC. Enhancement of human immunodeficiency virus (HIV)-specific CD4+ and CD8+ cytotoxic T-lymphocyte activities in HIV-infected asymptomatic patients given recombinant gp160 vaccine. Proc Natl Acad Sci U S A. 1992 Dec 1;89(23):11204-8. doi: 10.1073/pnas.89.23.11204.
Other Identifiers
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11112
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 137
Identifier Type: -
Identifier Source: org_study_id