Effects of Therapeutic HIV Vaccination on Control of HIV After Discontinuation of Anti-HIV Drugs
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ClinicalTrials.gov Identifier: NCT00050063 |
Recruitment Status
:
Completed
First Posted
: November 21, 2002
Last Update Posted
: May 21, 2012
|
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Condition or disease | Intervention/treatment |
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HIV Infections | Biological: Therapeutic vaccinations from A5058s |
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.
Study Type : | Observational |
Enrollment : | 78 participants |
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 |
Actual Study Completion Date : | May 2004 |

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Biological: Therapeutic vaccinations from A5058s

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00050063
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 | |
Indiana Univ. School of Medicine, Wishard Memorial | |
Indianapolis, Indiana, United States, 46202 | |
Methodist Hosp. of Indiana | |
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 | |
Beth Israel Deaconess Med. Ctr., ACTG CRS | |
Boston, Massachusetts, United States, 02215 | |
Brigham and Women's Hosp. ACTG CRS | |
Boston, Massachusetts, United States, 02215 | |
United States, New York | |
Beth Israel Med. Ctr., ACTU | |
New York, New York, United States, 10003 | |
NY Univ. HIV/AIDS CRS | |
New York, New York, United States, 10016-6481 | |
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 |
Study Chair: | Spyros Kalamus, M. D. | Vanderbilt University Medical Center | |
Study Chair: | Fred Valentine, M. D. | NYU MEDICAL CENTER |
Publications:
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00050063 History of Changes |
Other Study ID Numbers: |
A5172 10184 ( Registry Identifier: DAIDS ES Registry Number ) ACTG A5172 |
First Posted: | November 21, 2002 Key Record Dates |
Last Update Posted: | May 21, 2012 |
Last Verified: | May 2012 |
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 Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Vaccines Immunologic Factors Physiological Effects of Drugs |