Effects of Therapeutic HIV Vaccination on Control of HIV After Discontinuation of Anti-HIV Drugs

NCT00050063 | Completed

• 3 other identifiers: A517210184ACTG A5172
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 14

Brief Summary

The purpose of this study is to determine whether therapeutic HIV vaccines can help the immune system control HIV viral load after anti-HIV drugs are discontinued.

Conditions

HIV Infections

Keywords

HIV Therapeutic Vaccine; Treatment Experienced; AIDS Vaccines; Treatment Interruption; Viral Load; T-Lymphocytes, Cytotoxic; T-Lymphocytes, Helper-Inducer

Interventions

Therapeutic vaccinations from A5058s BIOLOGICAL

Participants will receive assigned interventions assigned in study A5058s.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participation in A5058s and receipt of a minimum of 7 sets of injections on that study
• Continuation of the same stable antiretroviral treatment that was given in A5058s for the last 3 months prior to A5172 entry, unless the regimen was changed for toxicity in the absence of virologic failure
• No less than 6 weeks and no more than 18 weeks since the last injection on A5058s prior to A5172 entry
• CD4+ T-cell count \> 300 cells/mm3 obtained within 30 days prior to study entry
• HIV-1 RNA \< 500 copies/ml obtained within 30 days prior to study entry
• Agreement to use approved methods of contraception

You may not qualify if:

• Pregnancy or breast-feeding
• Any of the following within 30 days prior to entry: acute infection requiring antibiotics, outbreak of herpes simplex virus (HSV) or herpes zoster, other acute medical illness, or surgery
• Symptomatic chronic infections other than HIV
• Malignancy that may require systemic therapy
• History of lymph node irradiation
• Use of immunoenhancing or immunosuppressive drugs within 30 days prior to entry, or any underlying disease of sufficient severity that these excluded drugs may be prescribed
• Hydroxyurea within 30 days prior to study entry
• Use of GM-CSF, G-CSF, M-CSF, IFN, IL-2, or other cytokines within 30 days prior to study entry
• Active drug or alcohol use or dependence that would interfere with adherence to study requirements
• Serious illness requiring systemic treatment and/or hospitalization until patient either completes therapy or is clinically stable on therapy for at least 30 days prior to study entry

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (14)

Harbor-UCLA Med. Ctr. CRS

Torrance, California, 90502-2052, United States

Location

University of Colorado Hospital CRS

Aurora, Colorado, 80262, United States

Location

Indiana Univ. School of Medicine, Infectious Disease Research Clinic

Indianapolis, Indiana, 46202, United States

Location

Indiana Univ. School of Medicine, Wishard Memorial

Indianapolis, Indiana, 46202, United States

Location

Methodist Hosp. of Indiana

Indianapolis, Indiana, 46202, United States

Location

Massachusetts General Hospital ACTG CRS

Boston, Massachusetts, 02114, United States

Location

Bmc Actg Crs

Boston, Massachusetts, 02118, United States

Location

Beth Israel Deaconess Med. Ctr., ACTG CRS

Boston, Massachusetts, 02215, United States

Location

Brigham and Women's Hosp. ACTG CRS

Boston, Massachusetts, 02215, 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, 10016-6481, United States

Location

Unc Aids Crs

Chapel Hill, North Carolina, 27514, United States

Location

Case CRS

Cleveland, Ohio, 44106-5083, United States

Location

Univ. of Texas Medical Branch, ACTU

Galveston, Texas, 77555, United States

Location

Related Publications (5)

• Papasavvas E, Ortiz GM, Gross R, Sun J, Moore EC, Heymann JJ, Moonis M, Sandberg JK, Drohan LA, Gallagher B, Shull J, Nixon DF, Kostman JR, Montaner LJ. Enhancement of human immunodeficiency virus type 1-specific CD4 and CD8 T cell responses in chronically infected persons after temporary treatment interruption. J Infect Dis. 2000 Sep;182(3):766-75. doi: 10.1086/315748. Epub 2000 Aug 17.

  PMID: 10950770 BACKGROUND

• Carcelain G, Tubiana R, Samri A, Calvez V, Delaugerre C, Agut H, Katlama C, Autran B. Transient mobilization of human immunodeficiency virus (HIV)-specific CD4 T-helper cells fails to control virus rebounds during intermittent antiretroviral therapy in chronic HIV type 1 infection. J Virol. 2001 Jan;75(1):234-41. doi: 10.1128/JVI.75.1.234-241.2001.

  PMID: 11119593 BACKGROUND

• Deeks SG, Wrin T, Liegler T, Hoh R, Hayden M, Barbour JD, Hellmann NS, Petropoulos CJ, McCune JM, Hellerstein MK, Grant RM. Virologic and immunologic consequences of discontinuing combination antiretroviral-drug therapy in HIV-infected patients with detectable viremia. N Engl J Med. 2001 Feb 15;344(7):472-80. doi: 10.1056/NEJM200102153440702.

  PMID: 11172188 BACKGROUND

• Ruiz L, Carcelain G, Martinez-Picado J, Frost S, Marfil S, Paredes R, Romeu J, Ferrer E, Morales-Lopetegi K, Autran B, Clotet B. HIV dynamics and T-cell immunity after three structured treatment interruptions in chronic HIV-1 infection. AIDS. 2001 Jun 15;15(9):F19-27. doi: 10.1097/00002030-200106150-00001.

  PMID: 11416734 BACKGROUND

• Garcia F, Plana M, Vidal C, Cruceta A, O'Brien WA, Pantaleo G, Pumarola T, Gallart T, Miro JM, Gatell JM. Dynamics of viral load rebound and immunological changes after stopping effective antiretroviral therapy. AIDS. 1999 Jul 30;13(11):F79-86. doi: 10.1097/00002030-199907300-00002.

  PMID: 10449278 BACKGROUND

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Spyros Kalamus, M. D.

  Vanderbilt University Medical Center

  STUDY CHAIR

• Fred Valentine, M. D.

  NYU MEDICAL CENTER

  STUDY CHAIR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2002
• First Posted: November 21, 2002
• Study Completion: May 1, 2004
• Last Updated: November 1, 2021

Record last verified: 2021-10

Locations

US (14)