A Placebo-Controlled, Phase I, Pilot Clinical Trial to Evaluate the Safety and Immunogenicity of ENV 2-3, a Yeast-Derived Recombinant Envelope Protein of Human Immunodeficiency Virus-1, in Combination With MTP-PE/MF59 in Individuals With HIV Infection (Placebo Patients Receive MF59 Emulsion Only)

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

By vaccinating those who have HIV infection, perhaps the replication (reproduction) of existing viral strains can be suppressed and the asymptomatic period early in the infectious process can be prolonged. One potential way to do this is to boost HIV antigen-specific CD4 responses, which may in turn increase the effectiveness of CD8 killing of HIV infected cells.

Eight patients are entered in the pilot portion of the study, thirty patients are entered on Part A and fifteen patients are entered on Part B. In the pilot study, patients receive 30 mcg Env 2-3 vaccine plus 0 - 10 mcg MTP-PE/MF5...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Patients must be:
• • Healthy HIV-seropositive adults (generalized lymphadenopathy, seborrheic dermatitis acceptable).
• • Negative for HIV plasma culture.
• • Available for 6 months follow-up (patients in Pilot study) or 10 months follow-up (patients in Parts A and B).
• Prior Medication: Required:
• • Part B: Zidovudine (AZT), tolerating a dose of 500 - 600 mg/day for at least 4 months prior to entry.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following conditions or symptoms are excluded:
• • Evidence of psychological disorder during the past year that would impair adherence to the protocol.
• • Evidence of an AIDS defining opportunistic infection.
• Prior Medication:
• Excluded:
• • Any potential immunomodulating agents (e.g., isoprinosine, imuthiol, lithium) within 90 days of screening.
• • Immunosuppressive medications during the past 3 months.
• • Part A: Use of zidovudine (AZT) for more than 30 days in the preceding 6 months, or any AZT within the last 30 days.
• • Parts A and B: Any non-AZT antiretroviral drug.
• • Any other investigational agent within the past 30 days.
• • Immunoglobulins within the past 60 days.
• Patients may not have the following prior conditions:
• • Evidence of psychological disorder during the past year that would impair adherence to the protocol.
• • History of an AIDS-defining opportunistic infection.
• • Use of illicit drugs or significant amounts of alcohol that, in the opinion of the principal investigator, would interfere with compliance with the study.