NCT00006509

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2000

Completed
10 months until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
5.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

March 9, 2015

Status Verified

March 1, 2015

First QC Date

November 17, 2000

Last Update Submit

March 5, 2015

Conditions

HIV Infections

Keywords

Recombinant ProteinsHIV Envelope Protein gp160AIDS VaccinesAnti-HIV AgentsTreatment ExperiencedHIV Therapeutic Vaccine

Interventions

ALVAC(2)120(B,MN)GNP (vCP1452)BIOLOGICAL
gp160 MN/LAI-2BIOLOGICAL

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aaron Diamond AIDS Res Ctr

New York, New York, 10016, United States

Location

Related Publications (3)

  • 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)

    BACKGROUND

  • 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. doi: 10.1128/jvi.76.5.2206-2216.2002.

    PMID: 11836398BACKGROUND

  • 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. doi: 10.1086/342559. Epub 2002 Aug 9.

    PMID: 12195350BACKGROUND

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • David Ho

    PRINCIPAL INVESTIGATOR

  • Martin Markowitz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

November 17, 2000

First Posted

August 31, 2001

Study Completion

June 1, 2007

Last Updated

March 9, 2015

Record last verified: 2015-03

Locations

US(1)