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A Study of the Safety and Effectiveness of an HIV Vaccine for HIV-Positive Patients Receiving Anti-HIV Drugs for at Least 2 Years

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2004 by National Institute of Allergy and Infectious Diseases (NIAID).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00006509
First received: November 17, 2000
Last updated: July 29, 2008
Last verified: December 2004

November 17, 2000
July 29, 2008
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Complete list of historical versions of study NCT00006509 on ClinicalTrials.gov Archive Site
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A Study of the Safety and Effectiveness of an HIV Vaccine for HIV-Positive Patients Receiving Anti-HIV Drugs for at Least 2 Years
A Phase I/II Safety and Immunogenicity Evaluation of a Prime/Boost Vaccine Using ALVAC-HIV (vCP 1452) With Recombinant gp160 LAI/MN-2 in HIV-Infected Subjects Treated With Antiretroviral Therapy for a Minimum of 2 Years

The purpose of this study is to see if 2 study vaccines, ALVAC-HIV (vCP1452) and gp160 MN/LAI-2, are safe and effective in boosting the body's attacks on HIV in HIV-positive patients.

HIV-infected patients who have been treated with anti-HIV drugs for a long time may have weakened immune responses. One way to strengthen these responses may be to have a safe and effective vaccine, which will boost immune responses that are specific to HIV.

HIV-infected patients treated with antiretroviral therapy for prolonged periods of time may show decreased levels of HIV-specific immune responses. In these patients, a prime-boost vaccine strategy may induce both humoral and cell-mediated immunity. The hypothesis of this study is that the vaccine strategy selected will be both safe and immunogenic in the patient population being tested.

Patients continue antiretroviral medications throughout the course of this study. All patients receive intramuscular injections of ALVAC-HIV (vCP 1452) and recombinant soluble gp160 MN/LAI-2 on Days 0, 30, 90, and 180. Patients are monitored for safety 30 minutes after each immunization and by telephone contact within 72 hours of each vaccination. In addition, each patient records adverse events in a diary. Patients have regular physical exams, pregnancy tests, and blood drawn for virologic and immunologic assessments. The induction of HIV-specific responses will be measured.

Interventional
Phase 1
Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Biological: ALVAC(2)120(B,MN)GNP (vCP1452)
  • Biological: gp160 MN/LAI-2
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
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Inclusion Criteria

Patients may be eligible for this study if they:

  • Are HIV-positive.
  • Have a viral load (amount of HIV in the blood) of less than 50 copies/ml.
  • Have been taking anti-HIV drugs for at least 2 years.
  • Are already participating in ongoing clinical trials at the Aaron Diamond AIDS Research Center.
  • Are at least 19 years old.
  • Practice abstinence or use 2 barrier methods of birth control, both men and women who are able to have children.

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Have HIV infection that is spreading through the body even though they are taking anti-HIV drugs.
  • Are breast-feeding.
  • Are pregnant.
  • Are allergic to eggs and/or neomycin.
  • Show evidence of poor immune responses.
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006509
AIEDRP AI-04-006, GCRC M01-RR00102, U01AI41534-01, PMC/ADARC-001
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National Institute of Allergy and Infectious Diseases (NIAID)
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Principal Investigator: David Ho
Principal Investigator: Martin Markowitz
National Institute of Allergy and Infectious Diseases (NIAID)
December 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP