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)

NCT00000958 | Completed Phase 1

• 4 other identifiers: AVEG 10311546AVEG 103AAVEG 103B
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the safety and immunogenicity of Env 2-3 in combination with MTP-PE/MF59 adjuvant in adult volunteers with HIV infection. 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.

Conditions

HIV Infections

Keywords

Vaccines, Synthetic; Recombinant Proteins; Adjuvants, Immunologic; Acquired Immunodeficiency Syndrome; HIV Envelope Protein gp120; AIDS Vaccines; HIV Therapeutic Vaccine

Interventions

MTP-PE/MF59 BIOLOGICAL

Env 2-3 BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Biocine: collaborator

Study Sites (1)

Univ. of Rochester AVEG

Rochester, New York, 14642, United States

Location

Related Publications (2)

• Keefer MC, Graham BS, McElrath MJ, Matthews TJ, Stablein DM, Corey L, Wright PF, Lawrence D, Fast PE, Weinhold K, Hsieh RH, Chernoff D, Dekker C, Dolin R. Safety and immunogenicity of Env 2-3, a human immunodeficiency virus type 1 candidate vaccine, in combination with a novel adjuvant, MTP-PE/MF59. NIAID AIDS Vaccine Evaluation Group. AIDS Res Hum Retroviruses. 1996 May 20;12(8):683-93. doi: 10.1089/aid.1996.12.683.

  PMID: 8744579 BACKGROUND

• Mohamed OA, Ashley R, Goldstein A, McElrath J, Dalessio J, Corey L. Detection of rectal antibodies to HIV-1 by a sensitive chemiluminescent western blot immunodetection method. J Acquir Immune Defic Syndr (1988). 1994 Apr;7(4):375-80.

  PMID: 8133447 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Study Officials

• Corey L

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: September 1, 1995
• Last Updated: November 4, 2021

Record last verified: 2021-10

Locations

US (1)