A Phase I/II Double-Blind Controlled Trial to Determine the Safety and Immunogenicity of HIV-1 MN rgp160 Immuno AG Vaccine Therapy in HIV-Infected Individuals With Greater Than or Equal to 500/mm3 CD4+ T Cells and 200-400/mm3 CD4+ T Cells

NCT00000822 | Completed Phase 1

• 3 other identifiers: ACTG 246/9461122311499
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and immunogenicity of HIV-1 MN rgp160 (Immuno-AG) in HIV-infected patients. To evaluate the immunogenicity of HIV-1 MN rgp160 immunogen by lymphocyte proliferation, specific antibody responses, and DTH reaction. To describe the durability of the immunogen in patients who respond to the first 7 injections when they are boosted every 8 weeks for an additional 6-12 months \[AS PER AMENDMENT 11/12/96: stratum 1 patients only\]. To describe the ability of the immunogen to induce a response after an additional 6-12 months of injections among patients who did not respond to the first 7 injections \[AS PER AMENDMENT 11/12/96: stratum 1 patients only\]. HIV-specific cellular immune responses appear to play an important role in HIV disease progression since both T helper and cytotoxic function against HIV decrease with disease progression.

Conditions

HIV Infections

Keywords

Vaccines, Synthetic; Didanosine; Drug Therapy, Combination; HIV Envelope Protein gp160; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Stavudine; HIV Protease Inhibitors; AIDS Vaccines; Ritonavir; Reverse Transcriptase Inhibitors; HIV Therapeutic Vaccine

Interventions

Ritonavir DRUG

gp160 Vaccine (Immuno-AG) BIOLOGICAL

Stavudine DRUG

Didanosine DRUG

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Concurrent Medication:
• Allowed:
• ddI \[AS PER AMENDMENT 11/12/96: and d4T\]. (Note:
• Patients in the stratum receiving only vaccine or control may take ddI \[AS PER AMENDMENT 11/12/96:
• and d4T\] ONLY IF their CD4 counts have shown a sustained decrease on two consecutive occasions 10-14 days apart.)
• PCP prophylaxis.
• Treatment for acute conditions, as indicated.
• AS PER AMENDMENT 11/12/96:
• Co-enrollment on other research trials.
• Patients must have:
• HIV positivity.
• Asymptomatic disease.
• CD4 count \>= 50 cells/mm3 (CD4 count must be 50-499 cells/mm3 in patients receiving ddI plus vaccine or control, and must be \>= 500 cells/mm3 in patients receiving vaccine or control only)
• \[AS PER AMENDMENT 11/12/96:
• CD4 count \>= 500 cells/mm3 for stratum 1 patients and 200-400 for stratum 2 patients\].

You may not qualify if:

• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• Medical contraindication to study participation or inability to comply with study requirements.
• Grade 2 or worse peripheral neuropathy (applicable only to patients receiving ddI plus vaccine or control).
• Concurrent Medication:
• Excluded:
• Immunomodulating agents, such as inosiplex, ditiocarb sodium, lithium, interferons, interleukin-2, and systemic steroids.
• Any antiretroviral therapy that may increase the risk of peripheral neuropathy (e.g., stavudine, zalcitabine \[AS PER AMENDMENT 11/12/96:
• e.g., zalcitabine or lamivudine\]).
• Agents such as IV pentamidine that may increase the risk of pancreatitis.
• Standard of care vaccines (in patients receiving vaccine) \[AS PER AMENDMENT 11/12/96:
• Standard of care immunizations are permitted 60 days before Schedule 1 vaccine therapy and during Schedule 2 vaccine therapy (but not within 2 weeks of study immunization)\].
• AS PER AMENDMENT 11/12/96:
• Rifabutin, disulfiram (antabuse), or other medication with similar effects, including metronidazole.
• AS PER AMENDMENT 11/12/96:

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Bristol-Myers Squibb: collaborator
• Immuno-US: collaborator

Study Sites (1)

Stanford CRS

Stanford, California, 943055107, United States

Location

Related Publications (2)

• Katzenstein D, Valentine F, Kundu S, Haslett P, Smith G, Merigan T. Delayed-type-hypersensitivity reactions to intradermal gp160 in HIV infected individuals immunized with gp160. Int Conf AIDS. 1992 Jul 19-24;8(2):A35 (abstract no PoA 2192)

  BACKGROUND

• Kundu-Raychaudhuri S, Sevin A, Kilgo P, Nokta M, Pollard RB, Merigan TC. Effect of therapeutic immunization with HIV type 1 recombinant glycoprotein 160 ImmunoAG vaccine in HIV-infected individuals with CD4+ T cell counts of >or=500 and 200-400/mm3 (AIDS Clinical Trials Group Study 246/946). AIDS Res Hum Retroviruses. 2001 Oct 10;17(15):1371-8. doi: 10.1089/088922201753197033.

  PMID: 11679149 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; AIDS-Related Complex

Interventions

Ritonavir; Stavudine; Didanosine

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

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thymidine; Pyrimidine Nucleosides; Pyrimidines; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Inosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ribonucleosides

Study Officials

• Kundu Smriti

  STUDY CHAIR

• Merigan T

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: May 1, 1999
• Last Updated: October 29, 2021

Record last verified: 2021-10

Locations

US (1)