Status:

COMPLETED

A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Vaccinia Derived HIV-1 Recombinant Envelope Glycoprotein (gp160) of Human Immunodeficiency Virus: Evaluation of a 200-mcg Dose

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborating Sponsors:

Immuno-US

Conditions:

HIV Infections

Eligibility:

All Genders

18-60 years

Phase:

PHASE1

Brief Summary

To determine the safety of and immune response to vaccinia-derived HIV-1 recombinant envelope glycoprotein (gp160) at a dose of 200 mcg in human volunteers; to evaluate duration of antibody response a...

Detailed Description

Although recent advances have been made in antiviral therapy against AIDS, there is currently no cure for AIDS. It is likely that the ultimate control of the disease depends on the development of safe...

Eligibility Criteria

Inclusion Criteria

Patients must be:

  • Normal, healthy, HIV-negative adults who fully comprehend the purpose and details of the study.
  • Available for 2 years of follow-up.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • History of positive PPD (tuberculin test) and abnormal chest x-ray.
  • Positive syphilis serology (e.g., RPR).
  • Positive for circulating hepatitis B surface antigen.

Patients with the following are excluded:

  • They or their sexual partners have identifiable high-risk behavior for HIV infection.
  • History of immunodeficiency or chronic illness.
  • Evidence of psychological or psychiatric problems that may lead to noncompliance.

Prior Medication:

Excluded:

  • Immunosuppressive medications.

Prior Treatment:

Excluded:

  • Blood transfusions or cryoprecipitates within the past 6 months.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 1994

Estimated Enrollment :

25 Patients enrolled

Trial Details

Trial ID

NCT00001056

End Date

October 1 1994

Last Update

November 4 2021

Active Locations (3)

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Page 1 of 1 (3 locations)

1

St. Louis Univ. School of Medicine AVEG

St Louis, Missouri, United States, 63104

2

Univ. of Rochester AVEG

Rochester, New York, United States, 14642

3

Vanderbilt Univ. Hosp. AVEG

Nashville, Tennessee, United States, 37232