Effectiveness of Adding Remune to Your Current Anti-HIV Drug Combination

This study has been terminated.
Sponsor:
Collaborator:
The Immune Response Corporation
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00006153
First received: August 7, 2000
Last updated: July 29, 2008
Last verified: June 2003
  Purpose

The purpose of this study is to see if giving a vaccine (Remune) is effective in HIV-positive patients who are also taking anti-HIV therapy.

Regular treatment of HIV-positive patients with anti-HIV drugs slows the multiplication of the HIV virus in the body. A vaccine called Remune works to stop the virus infection by "boosting" the body's immune cell defense against the HIV virus before the virus enters cells. It also blocks the virus from entering the cells. This study will see whether Remune will improve the immune cell natural defense in patients who are also taking anti-HIV drugs.


Condition Intervention Phase
HIV Infections
Biological: HIV-1 Immunogen
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Phase I, Adjuvant Controlled Study to Evaluate the Effect of Remune (HIV-1 Immunogen) Compared to IFA, in Combination With Fully Suppressive Antiviral Drug Therapy on HIV-1-Specific Immunogenicity in Subjects With Acute or Primary HIV-1 Infection

Resource links provided by NLM:


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

Estimated Enrollment: 45
Detailed Description:

During primary HIV infection, after an initial burst in viral load, the body mounts an immunologic response to viral antigens. It is thought that this initial immune response plays an important role in determining early and long-term suppression of HIV. However, limited information is available regarding the effect of early antiretroviral therapy on immune responses. Therapeutic approaches such as Remune, which augment cell-mediated immunologic responses, may prove to be beneficial in controlling the progression of HIV infection, especially when used in combination with antiretroviral therapy in early infection. Current antiviral drugs work by inhibiting the infection of new cells yet seem to suppress early cell-mediated immune responses. The question is raised as to whether immune-based therapies such as Remune may counteract the suppressive effects of antiretrovirals and slow the progression of infection.

Patients receiving fully suppressive antiretroviral therapy are randomized to add either Remune or an Incomplete Freund's Adjuvant (IFA) control. Vaccinations are administered on Day 1, Week 12, and Week 24. Blood samples are collected at Day 1 and Weeks 4, 12, 16, 24, and 28. Clinical assessment includes lymphocyte proliferative response, cytotoxic T lymphocyte (CTL) memory cell activity, chemokine and cytokine measurements, CD4 count, and viral load. Delayed-type hypersensitivity (DTH) skin tests are performed at Day 1 and Week 28. HIV-1 specific immunogenicity is coordinated with the response to antiretroviral therapy in patients.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

  • Are HIV-positive and started anti-HIV drugs soon after tests showed the presence of HIV.
  • Have been on an anti-HIV drug combination that includes a protease inhibitor for at least 3 months but no longer than 12 months.
  • Have 2 consecutive viral loads of less than 50 copies/ml, at least 30 days apart, within 90 days of study entry.
  • Are at least 16 years old (consent of parent or guardian required if under 18 years).
  • Agree to practice abstinence or use effective methods of birth control during the study.

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Are pregnant or breast-feeding.
  • Currently abuse alcohol or drugs.
  • Are currently being treated for some types of cancer.
  • Have any illness or condition that might interfere with the study or put them at risk.
  • Have received a vaccination 6 weeks before study entry.
  • Have previously received Remune.
  • Are taking medications that affect the immune system within 30 days of study entry.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006153

Locations
United States, California
Joanne Santangelo
San Diego, California, United States, 92103
Sponsors and Collaborators
The Immune Response Corporation
Investigators
Principal Investigator: Eric Daar
Principal Investigator: Susan Little
Principal Investigator: Janis Giorgi
Principal Investigator: Rachel Schrier
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00006153     History of Changes
Other Study ID Numbers: AIEDRP AI-05-006, 905
Study First Received: August 7, 2000
Last Updated: July 29, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
HIV Antibodies
Immunity, Cellular
Drug Therapy, Combination
Anti-HIV Agents
remune
HIV Therapeutic Vaccine

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on October 01, 2014