Search / Trial NCT00000667

A Phase I/II Dose Escalation Study of Intradermal gp160 to Evaluate Safety, Delayed Type Hypersensitivity (Skin Test) Responses and Immunogenicity in Asymptomatic HIV Seropositive Patients With More Than 400 CD4+ Cells

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of March 02, 2024

Completed

Keywords

Vaccines, Synthetic Injections, Intradermal Hiv Antigens Hiv Seropositivity Hiv 1 Drug Evaluation Hypersensitivity, Delayed Aids Vaccines Hiv Therapeutic Vaccine

Description

Early immunity to HIV may play an important role in the long interval between virus infection and the onset of clinical disease. Immune responses have been demonstrated in HIV-infected individuals within weeks to months of infection. Although none of these responses has been shown to be protective, it is possible that boosting anti-HIV immune responses through immunization may slow the progression of HIV infection. DTH responses to HIV-derived recombinant envelope glycoprotein could provide a means of measuring an important immune function in infected patients, and serve as an easily measur...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Acute use (< 14 days) of acyclovir for Herpes simplex virus infections or ketoconazole for symptomatic Candida infections.
  • Patients must have the following:
  • Asymptomatic HIV seropositivity.
  • 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:
  • Systemic symptoms other than lymphadenopathy thought to be due to HIV infection including:
  • Fatigue/malaise of > 1 month duration that interferes with normal activities.
  • Fever of > 100 degrees F persisting for > 15 in a 30-day interval without definable cause.
  • Involuntary weight loss in excess of 10 pounds or > 10 percent of normal weight within a 6-month interval.
  • Diarrhea (> 3 stools/day) persisting for more than 30 days without definable cause.
  • Recurrent oral candidiasis.
  • Multidermatomal herpes zoster.
  • Biopsy proven hairy leukoplakia.
  • Evidence of clinically significant central nervous system dysfunction as assessed by neurological exam.
  • Concurrent Medication:
  • Excluded:
  • Antiretroviral agents of proven or potential efficacy.
  • 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 other than lymphadenopathy thought to be due to HIV infection as listed in the patient exclusion coexisting diseases or complications.
  • 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).
  • Any potential antiretroviral.
  • Immunomodulating agents.
  • Active substance abuse (either continuing daily alcohol abuse or intravenous drug use).

Attachments

readout_NCT00000667_2024-03-02.pdf

4.5 MB

NCT00000667_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

New York, New York, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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