NCT00080106

Brief Summary

HIV vaccines may help the immune systems of HIV infected patients better control the virus. The goal of this study is to determine whether patients on anti-HIV medications can stop taking those medications if they receive an HIV vaccine. While taking anti-HIV medications, participants will receive either an HIV vaccine or a placebo. Participants will then stop taking their anti-HIV medications and the study will compare the viral loads of participants who received the vaccine with the viral loads of participants who received the placebo. Primary study hypotheses: 1)The Week 12 and Week 16 post-ART interruption geometric mean HIV-1 RNA levels will be lower among participants who had received MRK Ad5 vaccine prior to ART interruption than among participants who received placebo; 2) the time averaged area under the curve of the log10 HIV-1 RNA copies/ml versus day function in the 16 week post-ART interruption step will be lower among participants who received the MRK Ad5 vaccine prior to ART interruption than among participants who receive placebo.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
114

participants targeted

Target at P50-P75 for phase_2 hiv-infections

Timeline
Completed

Started Jun 2004

Longer than P75 for phase_2 hiv-infections

Geographic Reach
2 countries

28 active sites

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

March 23, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 25, 2004

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2004

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

November 9, 2021

Status Verified

July 1, 2013

Enrollment Period

3.3 years

First QC Date

March 23, 2004

Last Update Submit

November 4, 2021

Conditions

HIV Infections

Keywords

HIV Therapeutic VaccineTreatment ExperiencedTreatment InterruptionAdenovirus Vector

Outcome Measures

Primary Outcomes (2)

  • Analytical treatment interruption (ATI) HIV-1 RNA set-point

    Throughout study

  • ATI log10 HIV-1 RNA copies/ml at all scheduled evaluations during Step II (ATI)

    Throughout Step 2

Study Arms (2)

1

EXPERIMENTAL

Participants in the experimental arm will receive the MRK Ad5 HIV-1 gag vaccine on Day 1, Week 4 and Week 26. Participants will take their antiretroviral medications during the first 3 months of the study.

Biological: MRK Ad5 HIV-1 gag vaccine

2

PLACEBO COMPARATOR

Participants in Arm 2 will receive a placebo vaccine on Day 1, Week 4 and Week 26. Participants will take their antiretroviral medications during the first 3 months of the study.

Other: Vaccine placebo

Interventions

MRK Ad5 HIV-1 gag vaccineBIOLOGICAL

MRK Ad5 HIV-1 gag vaccine injected into the upper arm muscle.

1
Vaccine placeboOTHER

MRK Ad5 HIV-1 gag placebo vaccine injected into the upper arm muscle.

2

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • HIV infected
  • On a stable antiretroviral medication regimen (no changes to treatment within 4 weeks of study entry)
  • Viral load less than 50 copies/ml
  • Viral suppression for 2 years prior to study entry (documented viral loads less than 500 copies/ml)
  • CD4 count of 500 cells/mm3 or greater
  • Ad5 neutralizing antibody less than 200 units at screening
  • Willing to stop antiretroviral medications for at least 16 weeks post-vaccination
  • Hepatitis B surface antigen negative
  • Weight more than 110 lbs
  • Willing to use acceptable methods of contraception

You may not qualify if:

  • Two consecutive viral loads of 500 copies/ml or greater at least 14 days apart during the 24 months prior to study entry
  • Two consecutive CD4 counts less than 200 cells/mm3 before starting antiretroviral medications
  • History of anaphylaxis
  • Allergy to vaccine components
  • History of cardiac, pulmonary, gastrointestinal, hepatic, renal, pancreatic, or neurologic disease which, in the opinion of the study official, will compromise study participation
  • Pregnancy or breastfeeding
  • Contraindication to intramuscular injection, such as anticoagulant therapy or thrombocytopenia
  • Immune globulin or blood products within 3 months prior to study entry
  • Live vaccine within 30 days prior to study entry
  • Inactivated vaccine within 14 days prior to study entry
  • Previous HIV vaccine
  • History of an AIDS-defining illness. Patients with a history of Kaposi's sarcoma limited to the skin may participate.
  • Currently taking drugs or other substances not approved by the FDA. Patients may be on antiretroviral agents not yet approved by the FDA as part of a clinical trial or through an expanded access program.
  • Immunomodulatory agents (interferon, IL-2, GM-CSF, systemic corticosteroids, etc.) within 30 days prior to study entry
  • Active alcohol or substance abuse which may interfere with the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (28)

UCLA CARE Center CRS

Los Angeles, California, 90035, United States

Location

Stanford CRS

Palo Alto, California, 94304-5350, United States

Location

Univ. of California Davis Med. Ctr., ACTU

Sacramento, California, 95817, United States

Location

Ucsd, Avrc Crs

San Diego, California, 92103, United States

Location

Ucsf Aids Crs

San Francisco, California, 94110, United States

Location

Univ. of Miami AIDS CRS

Miami, Florida, 33136, United States

Location

Univ. of Hawaii at Manoa, Leahi Hosp.

Honolulu, Hawaii, 96816, United States

Location

Rush Univ. Med. Ctr. ACTG CRS

Chicago, Illinois, 60612, United States

Location

Indiana Univ. School of Medicine, Infectious Disease Research Clinic

Indianapolis, Indiana, 46202-5250, United States

Location

IHV Baltimore Treatment CRS

Baltimore, Maryland, 21201, United States

Location

Massachusetts General Hospital ACTG CRS

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Med. Ctr., ACTG CRS

Boston, Massachusetts, 02215, United States

Location

University of Minnesota, ACTU

Minneapolis, Minnesota, 55455, United States

Location

Washington U CRS

St Louis, Missouri, 63110, United States

Location

Beth Israel Med. Ctr., ACTU

New York, New York, 10003, United States

Location

NY Univ. HIV/AIDS CRS

New York, New York, 10016, United States

Location

Cornell CRS

New York, New York, 10021, United States

Location

AIDS Care CRS

Rochester, New York, 14607, United States

Location

Univ. of Rochester ACTG CRS

Rochester, New York, 14642, United States

Location

Unc Aids Crs

Chapel Hill, North Carolina, 27514, United States

Location

Case CRS

Cleveland, Ohio, 44106, United States

Location

MetroHealth CRS

Cleveland, Ohio, 44109, United States

Location

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Pitt CRS

Pittsburgh, Pennsylvania, 15213, United States

Location

The Miriam Hosp. ACTG CRS

Providence, Rhode Island, 02906, United States

Location

Univ. of Texas Medical Branch, ACTU

Galveston, Texas, United States

Location

University of Washington AIDS CRS

Seattle, Washington, 98104, United States

Location

Puerto Rico-AIDS CRS

San Juan, 00935, Puerto Rico

Location

Related Publications (8)

  • Shiver JW, Fu TM, Chen L, Casimiro DR, Davies ME, Evans RK, Zhang ZQ, Simon AJ, Trigona WL, Dubey SA, Huang L, Harris VA, Long RS, Liang X, Handt L, Schleif WA, Zhu L, Freed DC, Persaud NV, Guan L, Punt KS, Tang A, Chen M, Wilson KA, Collins KB, Heidecker GJ, Fernandez VR, Perry HC, Joyce JG, Grimm KM, Cook JC, Keller PM, Kresock DS, Mach H, Troutman RD, Isopi LA, Williams DM, Xu Z, Bohannon KE, Volkin DB, Montefiori DC, Miura A, Krivulka GR, Lifton MA, Kuroda MJ, Schmitz JE, Letvin NL, Caulfield MJ, Bett AJ, Youil R, Kaslow DC, Emini EA. Replication-incompetent adenoviral vaccine vector elicits effective anti-immunodeficiency-virus immunity. Nature. 2002 Jan 17;415(6869):331-5. doi: 10.1038/415331a.

    PMID: 11797011BACKGROUND

  • Ortiz GM, Wellons M, Brancato J, Vo HT, Zinn RL, Clarkson DE, Van Loon K, Bonhoeffer S, Miralles GD, Montefiori D, Bartlett JA, Nixon DF. Structured antiretroviral treatment interruptions in chronically HIV-1-infected subjects. Proc Natl Acad Sci U S A. 2001 Nov 6;98(23):13288-93. doi: 10.1073/pnas.221452198. Epub 2001 Oct 30.

    PMID: 11687611BACKGROUND

  • Moss RB, Brandt C, Giermakowska WK, Savary JR, Theofan G, Zanetti M, Carlo DJ, Wallace MR. HIV-specific immunity during structured antiviral drug treatment interruption. Vaccine. 2003 Mar 7;21(11-12):1066-71. doi: 10.1016/s0264-410x(02)00610-2.

    PMID: 12559781BACKGROUND

  • Schooley RT, Spritzler J, Wang H, Lederman MM, Havlir D, Kuritzkes DR, Pollard R, Battaglia C, Robertson M, Mehrotra D, Casimiro D, Cox K, Schock B; AIDS Clinical Trials Group 5197 Study Team. AIDS clinical trials group 5197: a placebo-controlled trial of immunization of HIV-1-infected persons with a replication-deficient adenovirus type 5 vaccine expressing the HIV-1 core protein. J Infect Dis. 2010 Sep 1;202(5):705-16. doi: 10.1086/655468.

    PMID: 20662716RESULT

  • Li JZ, Heisey A, Ahmed H, Wang H, Zheng L, Carrington M, Wrin T, Schooley RT, Lederman MM, Kuritzkes DR; ACTG A5197 Study Team. Relationship of HIV reservoir characteristics with immune status and viral rebound kinetics in an HIV therapeutic vaccine study. AIDS. 2014 Nov 28;28(18):2649-57. doi: 10.1097/QAD.0000000000000478.

    PMID: 25254301DERIVED

  • Li JZ, Christensen JA, Wang H, Spritzler J, Kuritzkes DR; AIDS Clinical Trials Group A5197 Study Team. Evaluation of HIV-1 ambiguous nucleotide frequency during antiretroviral treatment interruption. J Acquir Immune Defic Syndr. 2012 Sep 1;61(1):19-22. doi: 10.1097/QAI.0b013e318264460f.

    PMID: 22732468DERIVED

  • Li JZ, Brumme CJ, Lederman MM, Brumme ZL, Wang H, Spritzler J, Carrington M, Medvik K, Walker BD, Schooley RT, Kuritzkes DR; AIDS Clinical Trials Group A5197 Study Team. Characteristics and outcomes of initial virologic suppressors during analytic treatment interruption in a therapeutic HIV-1 gag vaccine trial. PLoS One. 2012;7(3):e34134. doi: 10.1371/journal.pone.0034134. Epub 2012 Mar 30.

    PMID: 22479542DERIVED

  • Li JZ, Brumme ZL, Brumme CJ, Wang H, Spritzler J, Robertson MN, Lederman MM, Carrington M, Walker BD, Schooley RT, Kuritzkes DR; AIDS Clinical Trials Group A5197 Study Team. Factors associated with viral rebound in HIV-1-infected individuals enrolled in a therapeutic HIV-1 gag vaccine trial. J Infect Dis. 2011 Apr 1;203(7):976-83. doi: 10.1093/infdis/jiq143.

    PMID: 21402549DERIVED

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

  • Robert T. Schooley, MD

    University of Colorado, Denver

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2004

First Posted

March 25, 2004

Study Start

June 1, 2004

Primary Completion

September 1, 2007

Study Completion

May 1, 2011

Last Updated

November 9, 2021

Record last verified: 2013-07

Locations

US(27)PR(1)