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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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