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)
MTP-PE/MF59
+ Env 2-3
Blood-Borne Infections+13
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
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/MF59 adjuvant. Patients on Part A receive one of the following: MF59 emulsion only; 100 mcg MTP-PE/MF59 only; 30 mcg Env 2-3 with MF59 emulsion only; or 30 mcg Env 2-3 vaccine with 100 mcg MTP-PE/MF59. Patients on Part B receive either 100 mcg MTP-PE/MF59 only or 30 mcg Env 2-3 vaccine plus 100 mcg MTP-PE/MF59. Treatment is administered on days 0, 28, and 112, and patients are followed for up to 10 months. Per amendment, patients may receive two additional doses of 30 mcg Env 2-3 or placebo in MTP-PE/MF59 at 7 and 10 months (Parts A and B) or 9 and 12 months (Pilot study) after their initial inoculation.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.8 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 50 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location