A Phase I Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of HIV-1 Recombinant Envelope Glycoprotein gp160

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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 AIDS, there is currently no cure. It is likely that ultimate control of the disease will depend on the development of safe and effective vaccines against HIV.

Key facts

Study ID

NCT00000745

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

72

Expected to finish

1991-05-01

Last updated by the study team

2021-11-04

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• JHU AVEG — Pittsburgh, Pennsylvania, United States
• Vanderbilt Univ. Hosp. AVEG — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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