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

First Received on November 17, 2000. Last Updated on July 29, 2008 History of Changes

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00006509

Purpose

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	Intervention	Phase
HIV Infections	Biological: ALVAC(2)120(B,MN)GNP (vCP1452) Biological: gp160 MN/LAI-2	Phase I

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS HIV/AIDS Medicines

U.S. FDA Resources

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

Estimated Enrollment:

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.

Eligibility

Ages Eligible for Study:	19 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.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006509

Locations

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)

Investigators

Principal Investigator:	David Ho
Principal Investigator:	Martin Markowitz

More Information

Additional Information:

Haga clic aquí para ver información sobre este ensayo clínico en español. This link exits the ClinicalTrials.gov site

Publications:

Jin X, Ramanathan M Jr, Barsoum S, Deschenes G, Ba L, Binley J, Hurley A, El Habib R, Caudrelierl P, Zhang L, Ho DD, Markowitz M. Safety and immunogenicity study of vCP1452/rgp160 therapeutic vaccines in patients treated with HAART for over two years. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 21)

Jin X, Ramanathan M Jr, Barsoum S, Deschenes GR, Ba L, Binley J, Schiller D, Bauer DE, Chen DC, Hurley A, Gebuhrer L, El Habib R, Caudrelier P, Klein M, Zhang L, Ho DD, Markowitz M. Safety and immunogenicity of ALVAC vCP1452 and recombinant gp160 in newly human immunodeficiency virus type 1-infected patients treated with prolonged highly active antiretroviral therapy. J Virol. 2002 Mar;76(5):2206-16.

Markowitz M, Jin X, Hurley A, Simon V, Ramratnam B, Louie M, Deschenes GR, Ramanathan M Jr, Barsoum S, Vanderhoeven J, He T, Chung C, Murray J, Perelson AS, Zhang L, Ho DD. Discontinuation of antiretroviral therapy commenced early during the course of human immunodeficiency virus type 1 infection, with or without adjunctive vaccination. J Infect Dis. 2002 Sep 1;186(5):634-43.

ClinicalTrials.gov Identifier:	NCT00006509 History of Changes
Other Study ID Numbers:	AIEDRP AI-04-006, GCRC M01-RR00102, U01AI41534-01, PMC/ADARC-001
Study First Received:	November 17, 2000
Last Updated:	July 29, 2008
Health Authority:	United States: Food and Drug Administration

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
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 February 09, 2012