Active Immunization of Asymptomatic, HIV-Infected Individuals With Recombinant GP160 HIV-1 Antigen: A Phase I/II Study of Immunogenicity and Toxicity
Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001
Trial Information
Current as of January 15, 2025
Completed
Keywords
ClinConnect Summary
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.
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...
Gender
ALL
Eligibility criteria
- • 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).
Trial Officials
Valentine F
Study Chair
About National Institute Of Allergy And Infectious Diseases (Niaid)
The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Palo Alto, California, United States
New York, New York, United States
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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