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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00050063
First received: November 20, 2002
Last updated: May 17, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
HIV Infections
Biological: Therapeutic vaccinations from A5058s

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Rollover Study of A5058s: A Phase II Trial to Evaluate the Ability of Vaccine-Induced Helper and CTL Responses to Control Viremia in the Absence of Antiretroviral Therapy

Resource links provided by NLM:


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

Estimated Enrollment: 78
Study Completion Date: May 2004
Intervention Details:
    Biological: Therapeutic vaccinations from A5058s
    Participants will receive assigned interventions assigned in study A5058s.
Detailed Description:

This study is a rollover study for patients who participated in A5058s: Augmentation of HIV-Specific Helper and CTL Responses Through Therapeutic Vaccination in Individuals Receiving Potent Suppressive Antiretroviral Therapies. In A5058s, patients received a series of therapeutic vaccinations to elicit HIV-specific immune responses. This study will examine whether these vaccine-induced responses can control viral load in the absence of antiretroviral therapy (ART).

Upon study entry, patients will discontinue ART. During the first 6 weeks of the study, viral load will be monitored weekly and CD4+ T-cell counts will be monitored every other week. Viral load and CD4+ T-cell counts will be measured every other week from Week 6 through Week 24, then monthly until patients restart ART or until Week 48. Patients who reinitiate ART for any reason will be registered to Step 2 and followed for 10 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00050063

Locations
United States, California
Harbor-UCLA Med. Ctr. CRS
Torrance, California, United States, 90502-2052
United States, Colorado
University of Colorado Hospital CRS
Aurora, Colorado, United States, 80262
United States, Indiana
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, United States, 46202
Methodist Hosp. of Indiana
Indianapolis, Indiana, United States, 46202
Indiana Univ. School of Medicine, Wishard Memorial
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Massachusetts General Hospital ACTG CRS
Boston, Massachusetts, United States, 02114
Bmc Actg Crs
Boston, Massachusetts, United States, 02118
Brigham and Women's Hosp. ACTG CRS
Boston, Massachusetts, United States, 02215
Beth Israel Deaconess Med. Ctr., ACTG CRS
Boston, Massachusetts, United States, 02215
United States, New York
NY Univ. HIV/AIDS CRS
New York, New York, United States, 10016-6481
Beth Israel Med. Ctr., ACTU
New York, New York, United States, 10003
United States, North Carolina
Unc Aids Crs
Chapel Hill, North Carolina, United States, 27514
United States, Ohio
Case CRS
Cleveland, Ohio, United States, 44106-5083
United States, Texas
Univ. of Texas Medical Branch, ACTU
Galveston, Texas, United States, 77555
Sponsors and Collaborators
Investigators
Study Chair: Spyros Kalamus, M. D. Vanderbilt University
Study Chair: Fred Valentine, M. D. NYU MEDICAL CENTER
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00050063     History of Changes
Other Study ID Numbers: A5172, 10184, ACTG A5172
Study First Received: November 20, 2002
Last Updated: May 17, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
HIV Therapeutic Vaccine
Treatment Experienced
AIDS Vaccines
Treatment Interruption
Viral Load
T-Lymphocytes, Cytotoxic
T-Lymphocytes, Helper-Inducer

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
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014