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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006509
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : March 9, 2015
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
HIV Infections Biological: ALVAC(2)120(B,MN)GNP (vCP1452) Biological: gp160 MN/LAI-2 Phase 1

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 12 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00006509

United States, New York
Aaron Diamond AIDS Res Ctr
New York, New York, United States, 10016
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: David Ho
Principal Investigator: Martin Markowitz

Publications: Identifier: NCT00006509     History of Changes
Other Study ID Numbers: AI-04-006
GCRC M01-RR00102
U01AI041534-01 ( U.S. NIH Grant/Contract )
AIEDRP AI-04-006
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: March 9, 2015
Last Verified: March 2015

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Recombinant Proteins
HIV Envelope Protein gp160
AIDS Vaccines
Anti-HIV Agents
Treatment Experienced
HIV Therapeutic Vaccine

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs