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A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Immuno-AG Recombinant HIV gp160 in Asymptomatic HIV Seropositive Individuals
This study has been completed.
Sponsors and Collaborators: Immuno-US
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000633
  Purpose

To determine the safety and immunogenicity of vaccinia-derived HIV-1 recombinant envelope glycoprotein (gp160) in asymptomatic HIV-infected adult volunteers. To compare safety and immunogenicity of two different schedules of gp160 administration. To examine the effects of gp160 and hepatitis B vaccine (Engerix-B) on various markers of viral load and on selected immune parameters.

Potentiation of a patient's immune response to HIV might possibly prolong the period of clinical latency and protect the patient indefinitely. Preliminary results from a study of Immuno-AG recombinant gp160 vaccine in healthy volunteers not infected with HIV suggest that the vaccine is safe and produces antibodies against the virus. Because another previous study failed to demonstrate a specific anti-HIV response in patients injected with a recombinant vaccinia virus containing HIV-1 genes, this study is also testing the immunotherapeutic role of other immunizations (such as hepatitis B vaccination) that would be expected to induce a nonspecific immune response in HIV-infected persons.


Condition Intervention Phase
HIV Infections
Biological: gp160 Vaccine (Immuno-AG)
Biological: Hepatitis B Vaccine (Recombinant)
Phase I

MedlinePlus related topics: AIDS Hepatitis Hepatitis B
Drug Information available for: Hepatitis B Vaccines PANVAC-V
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Placebo Control, Safety Study
Official Title: A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Immuno-AG Recombinant HIV gp160 in Asymptomatic HIV Seropositive Individuals

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 55
Detailed Description:

Potentiation of a patient's immune response to HIV might possibly prolong the period of clinical latency and protect the patient indefinitely. Preliminary results from a study of Immuno-AG recombinant gp160 vaccine in healthy volunteers not infected with HIV suggest that the vaccine is safe and produces antibodies against the virus. Because another previous study failed to demonstrate a specific anti-HIV response in patients injected with a recombinant vaccinia virus containing HIV-1 genes, this study is also testing the immunotherapeutic role of other immunizations (such as hepatitis B vaccination) that would be expected to induce a nonspecific immune response in HIV-infected persons.

Fifty-five healthy HIV-positive volunteers are randomly assigned to one of the following treatment arms: six injections (arm I) or four injections (arm II) of HIV-1 gp160 vaccine, four injections of hepatitis B vaccine as a non-HIV viral vaccine control (arm III), or six placebo injections consisting of the adjuvant vehicle used for the gp160 vaccine (arm IV). Immunizations or placebo are given at 4-week intervals for 5 months. To maintain blinding, adjuvant vehicle placebo is administered on days 84 and 112 to those volunteers receiving four instead of six vaccine injections (arms II and III). Volunteers are followed at 4-month intervals for 2 years.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Concurrent Medication: Recommended:

  • Prophylaxis with isoniazid in patients not previously treated.

Patients must have:

  • HIV seropositivity by Western blot.
  • Normal history and physical exam (generalized lymphadenopathy is acceptable).
  • Mean CD4 cell count = or > 600 cells/mm3 for all visits (minimum 2 counts) within 60 days prior to study entry, with no single count < 450 cells/mm3.
  • Negative PPD test or normal chest x-ray with positive PPD (induration = or > 5 mm).

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Hepatitis B surface antigen positive.
  • Evidence of an AIDS- or ARC-defining opportunistic infection.
  • Evidence of disseminated tuberculosis, severe or persistent candidiasis, oral hairy leukoplakia, prolonged or very severe diarrhea, herpes zoster, or herpes simplex persisting more than one month.
  • Active syphilis.

Patients with the following prior conditions are excluded:

  • Evidence of psychiatric disorder within the past year that would impair adherence to the protocol.
  • History of an AIDS- or ARC-defining opportunistic infection.
  • History of disseminated tuberculosis, severe or persistent candidiasis, oral hairy leukoplakia, prolonged or very severe diarrhea, herpes zoster, or herpes simplex persisting more than one month.

Prior Medication:

Excluded:

  • Immunomodulating agents (e.g., isoprinosine, imuthiol, lithium) within 90 days of screening.
  • Immunosuppressive medications within the previous 3 months.
  • Zidovudine (AZT) or any antiviral agent (including interferon) within the previous 6 months.
  • Vaccination against other pathogens within 4 weeks of initial screening laboratory work.

Use of illicit drugs or significant amounts of alcohol that could significantly interfere with study compliance.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000633

Locations
United States, Maryland
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21287
Johns Hopkins Univ / School of Hygiene & Public Health
Baltimore, Maryland, United States, 212051901
United States, Missouri
St Louis Univ School of Medicine
St. Louis, Missouri, United States, 63104
United States, South Carolina
Julio Arroyo
West Columbia, South Carolina, United States, 29169
United States, Tennessee
Vanderbilt Univ Hosp
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Immuno-US
Investigators
Study Chair: Schwartz D
  More Information

Publications:
Study ID Numbers: ACTG 205, AVEG 101
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00000633  
Health Authority: Unspecified

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Vaccines, Synthetic
Vaccinia Virus
Viral Vaccines
HIV-1
HIV Envelope Protein gp160
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
AIDS Vaccines
HIV Therapeutic Vaccine

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
Vaccinia
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 15, 2009