Status:
COMPLETED
A Phase I Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of HIV-1 Recombinant Envelope Glycoprotein gp160
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Protein Sciences Corporation
Conditions:
HIV Infections
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
To determine the reactivity and safety of HIV-1 recombinant envelope glycoprotein gp160. To determine the immunogenicity of gp160. Although recent advances have been made in antiviral therapy against...
Detailed Description
Although recent advances have been made in antiviral therapy against AIDS, there is currently no cure. It is likely that ultimate control of the disease will depend on the development of safe and effe...
Eligibility Criteria
Inclusion Criteria
Subjects must have:
- Normal history and physical exam.
- Negative for HIV infection by ELISA and Western blot (i.e., no reactivity at gp160, gp120, gp41, or p24).
- T4 count >= 800 cells/mm3.
- Normal chest x-ray and urinalysis.
- Negative surface antibody and core antibody for hepatitis B.
- Negative hepatitis B surface antigen.
- Negative HIV p24 antigen test.
- Normal skin reactivity by Merieux test.
Exclusion Criteria
Co-existing Condition:
Subjects with the following symptoms or conditions are excluded:
- Positive PPD.
- Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease).
Subjects with the following prior conditions are excluded:
- History of immunodeficiency, chronic illness, or use of immunosuppressive medications.
- Prior hepatitis B vaccination.
- Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months.
Prior Medication:
Excluded:
- Prior hepatitis B vaccine.
Prior Treatment:
Excluded:
- Prior blood transfusions or cryoprecipitates within the past 6 months.
Identifiable high-risk behavior for HIV infection (as determined by prescreening questions designed to identify risk factors for HIV infection), including:
- Any history of IV drug use.
- Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months.
- More than two sexual partners, or sexual contact with a high-risk partner, in the past 6 months.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
May 1 1991
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00000745
End Date
May 1 1991
Last Update
November 4 2021
Active Locations (2)
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1
JHU AVEG
Pittsburgh, Pennsylvania, United States
2
Vanderbilt Univ. Hosp. AVEG
Nashville, Tennessee, United States, 37232