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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00050063 |
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 |
|---|
|
HIV Infections |
| 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 |
| Estimated Enrollment: | 78 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Harbor General/UCLA | |
| Torrance, California, United States, 90502-2052 | |
| United States, Colorado | |
| Univ of Colorado Health Sciences Ctr, Denver | |
| Denver, Colorado, United States, 80262 | |
| United States, Indiana | |
| Indiana Univ Hosp | |
| Indianapolis, Indiana, United States, 46202 | |
| Methodist Hosp of Indiana | |
| Indianapolis, Indiana, United States, 46202 | |
| Wishard Hosp | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Massachusetts | |
| Harvard (Massachusetts General Hosp) | |
| Boston, Massachusetts, United States, 02114 | |
| Boston Med Ctr (Harvard) | |
| Boston, Massachusetts, United States, 02118 | |
| Brigham and Womens Hosp | |
| Boston, Massachusetts, United States, 02215 | |
| Beth Israel Deaconess- West Campus | |
| Boston, Massachusetts, United States, 02215 | |
| United States, New York | |
| NYU/Bellevue | |
| New York, New York, United States, 10016-6481 | |
| Beth Israel Med Ctr | |
| New York, New York, United States, 10003 | |
| United States, North Carolina | |
| Univ of North Carolina | |
| Chapel Hill, North Carolina, United States, 27514 | |
| United States, Ohio | |
| Case Western Reserve Univ | |
| Cleveland, Ohio, United States, 44106-5083 | |
| United States, Texas | |
| Univ of Texas, Galveston | |
| Galveston, Texas, United States, 77555 | |
| Study Chair: | Spyros Kalamus, M. D. | Vanderbilt University |
| Study Chair: | Fred Valentine, M. D. | NYU MEDICAL CENTER |
More Information
| ClinicalTrials.gov Identifier: | NCT00050063 History of Changes |
| Other Study ID Numbers: | ACTG A5172 |
| Study First Received: | November 20, 2002 |
| Last Updated: | March 29, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
HIV Therapeutic Vaccine Treatment Experienced AIDS Vaccines Treatment Interruption |
Viral Load T-Lymphocytes, Cytotoxic T-Lymphocytes, Helper-Inducer |
|
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 |