NCT00000667

Brief Summary

To determine the safety of intradermal gp160 in HIV seropositive individuals who are asymptomatic and have a relatively intact immune system. To determine whether there is evidence of a delayed-type hypersensitivity (DTH) response (a "positive" skin test) in these patients, and also the dose of gp160 that elicits a delayed-type hypersensitivity (DTH) response. 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 measured surrogate marker of cellular immunity. In addition to eliciting local, cutaneous DTH responses, intradermal inoculation of skin test antigens may be immunogenic, resulting in new antibody production and cellular immune responses. This study allows direct comparison of gp160 administered intradermally with alum-adjuvanted intramuscular preparation with respect to immunogenicity in HIV seropositive patients.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_1 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

July 1, 1993

Completed
6.3 years until next milestone

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

November 3, 2021

Status Verified

October 1, 2021

First QC Date

November 2, 1999

Last Update Submit

October 26, 2021

Conditions

HIV Infections

Keywords

Vaccines, SyntheticInjections, IntradermalHIV AntigensHIV SeropositivityHIV-1Drug EvaluationHypersensitivity, DelayedAIDS VaccinesHIV Therapeutic Vaccine

Interventions

gp160 Vaccine (MicroGeneSys)BIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NY Univ. HIV/AIDS CRS

New York, New York, 10016, United States

Location

Related Publications (2)

  • Katzenstein D, Valentine F, Kundu S, Haslett P, Smith G, Merigan T. Delayed-type-hypersensitivity reactions to intradermal gp160 in HIV infected individuals immunized with gp160. Int Conf AIDS. 1992 Jul 19-24;8(2):A35 (abstract no PoA 2192)

    BACKGROUND

  • 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.

    PMID: 10634195BACKGROUND

MeSH Terms

Conditions

HIV InfectionsHIV SeropositivityHypersensitivity, Delayed

Interventions

VaxSyn HIV-1 (gp160) vaccine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesHypersensitivity

Study Officials

  • Katzenstein DA

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
PREVENTION
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Completion

July 1, 1993

Last Updated

November 3, 2021

Record last verified: 2021-10

Locations

US(1)