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 Accelerated Schedules
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 evaluate the safety and immune response to vaccinia-derived HIV-1 recombinant envelope glycoprotein (gp160) using an accelerated dosage schedule; to evaluate duration of antibody response and its r...
Detailed Description
Although recent advances have been made in antiviral therapy against AIDS, there is currently no cure for AIDS. It is likely that ultimate control of the disease depends on the development of safe and...
Eligibility Criteria
Inclusion Criteria
Patients must be:
- Normal, healthy, HIV-negative adults who fully comprehend the purpose and details of the study.
- Available for 1 year of follow-up.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
- They or their sexual partners have identifiable high-risk behavior for HIV infection.
- Positive syphilis serology (e.g., VDRL).
- Positive for circulating hepatitis B antigen.
Patients with the following prior conditions are excluded:
- History of positive PPD (tuberculin test).
- History of immunodeficiency or chronic illness.
- Evidence of depression or under treatment for psychiatric problems during the past year.
Prior Medication:
Excluded:
- Immunosuppressive medications.
Prior Treatment:
Excluded:
- Blood transfusions or cryoprecipitates within the past 6 months.
Risk Behavior: Excluded:
- High-risk behavior for HIV infection.
- History of intravenous drug use.
- More than one sexual partner in the last 6 months.
- Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 1993
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00000957
End Date
August 1 1993
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
JHU AVEG
Pittsburgh, Pennsylvania, United States, 19104
3
Vanderbilt Univ. Hosp. AVEG
Nashville, Tennessee, United States, 37232