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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00006495 |
The purpose of this study is to see how the vaccines Remune (HIV-1 immunogen) and vCP1452 affect immune responses in patients who also are taking anti-HIV medications. This study also will see if these vaccines are safe to use either alone or in combination.
Treatment with anti-HIV drugs does not always keep HIV viral load low and under control. This study will look at the effect of the HIV vaccine, vCP1452, on the immune response and how it works in combination with Remune. Information about immune responses and the safety of these vaccines in HIV-positive patients will be gathered.
Condition | Intervention | Phase |
HIV Infections |
Biological: ALVAC(2)120(B,MN)GNP (vCP1452) Biological: HIV-1 Immunogen |
Phase I |
MedlinePlus related topics: | AIDS AIDS Medicines |
Study Type: | Interventional |
Study Design: | Treatment, Double-Blind, Safety Study |
Official Title: | Augmentation of HIV-Specific Helper and CTL Responses Through Therapeutic Vaccination in Individuals Receiving Potent Suppressive Antiretroviral Therapies |
Estimated Enrollment: | 80 |
Human viral infections are controlled by the immune system. However, the multiple immune responses provoked by HIV infection do not control the infection in most people. The ability to specifically augment CTL responses with an immunotherapeutic vaccine may strengthen the containment of viremia afforded by antiretroviral agents and thereby extend the durability of viral suppression. The current study will attempt to determine whether therapeutic immunizations with HIV-1 immunogen and vCP1452 are safe and able to augment HIV-1 specific immune responses for a longer period of time than antiretroviral therapy alone, and if both agents are better than either by itself.
Patients currently enrolled in A5058s under A5057/A5058s Versions 1.0 and 2.0 will be given the option of continuing their participation in A5058s through this independent study. Rollover patients register to Step II and begin treatment/evaluations on A5058s at the same study week that they were on in Versions 1.0 and 2.0 of A5057/A5058s. New patients enter Step I and will not need to register to Step II. Step I patients are stratified on the basis of HIV viral load, antiretroviral history, and current antiretroviral treatment. Within each stratum, patients are randomized to 1 of the following 4 treatment arms: HIV-1 immunogen plus ALVAC placebo, HIV-1 immunogen placebo plus ALVAC placebo, HIV-1 immunogen placebo plus vCP1452, or HIV-1 immunogen plus vCP1452. Patients receive an injection at study entry and every 12 weeks thereafter until the end of the study, a minimum of 2 years. Step II patients receive the same treatment as patients in Step I. Patients are evaluated every 12 weeks for clinical, immunologic, and virologic parameters. Patients continue taking the antiretroviral treatment that they were taking at study entry until reaching a virologic relapse as defined in the protocol. If no response to a new drug regimen occurs, or the antiretroviral therapy is not changed, immunizations may continue as long as the viral load remains below 5,000 copies/ml.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for Step I of this study if they:
Exclusion Criteria
Patients will not be eligible for Step I of this study if they:
United States, California | |||||
UCLA CARE Ctr | |||||
Los Angeles, California, United States, 90095 | |||||
Univ of Southern California / LA County USC Med Ctr | |||||
Los Angeles, California, United States, 900331079 | |||||
Harbor UCLA Med Ctr | |||||
Torrance, California, United States, 90502 | |||||
United States, Colorado | |||||
Univ of Colorado Health Sciences Ctr | |||||
Denver, Colorado, United States, 80262 | |||||
United States, Florida | |||||
Univ of Miami School of Medicine | |||||
Miami, Florida, United States, 331361013 | |||||
United States, Indiana | |||||
Indiana Univ Hosp | |||||
Indianapolis, Indiana, United States, 462025250 | |||||
Methodist Hosp of Indiana / Life Care Clinic | |||||
Indianapolis, Indiana, United States, 46202 | |||||
Wishard Hosp | |||||
Indianapolis, Indiana, United States, 46202 | |||||
United States, Maryland | |||||
Johns Hopkins Hosp | |||||
Baltimore, Maryland, United States, 21287 | |||||
United States, Massachusetts | |||||
Harvard (Massachusetts Gen Hosp) | |||||
Boston, Massachusetts, United States, 02114 | |||||
Brigham and Women's Hosp | |||||
Boston, Massachusetts, United States, 02215 | |||||
Boston Med Ctr | |||||
Boston, Massachusetts, United States, 02118 | |||||
Beth Israel Deaconess - West Campus | |||||
Boston, Massachusetts, United States, 02215 | |||||
United States, New York | |||||
Univ of Rochester Medical Center | |||||
Rochester, New York, United States, 14642 | |||||
Bellevue Hosp / New York Univ Med Ctr | |||||
New York, New York, United States, 10016 | |||||
SUNY / Erie County Med Ctr at Buffalo | |||||
Buffalo, New York, United States, 14215 | |||||
Beth Israel Med Ctr | |||||
New York, New York, United States, 10003 | |||||
Community Health Network Inc | |||||
Rochester, New York, United States, 14642 | |||||
St Mary's Hosp (Univ of Rochester/Infectious Diseases) | |||||
Rochester, New York, United States, 14642 | |||||
Columbia Presbyterian Med Ctr | |||||
New York, New York, United States, 10032 | |||||
United States, North Carolina | |||||
Univ of North Carolina | |||||
Chapel Hill, North Carolina, United States, 275997215 | |||||
Duke Univ Med Ctr | |||||
Durham, North Carolina, United States, 27710 | |||||
United States, Ohio | |||||
Case Western Reserve Univ | |||||
Cleveland, Ohio, United States, 44106 | |||||
MetroHealth Med Ctr | |||||
Cleveland, Ohio, United States, 441091998 | |||||
United States, Pennsylvania | |||||
Univ of Pennsylvania at Philadelphia | |||||
Philadelphia, Pennsylvania, United States, 19104 | |||||
United States, Texas | |||||
Univ of Texas Galveston | |||||
Galveston, Texas, United States, 775550435 |
Study Chair: | Spyros Kalams | |
Study Chair: | Fred Valentine |
Haga clic aquí para ver información sobre este ensayo clínico en español. 
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Study ID Numbers: | ACTG A5058s, AACTG A5058s |
First Received: | November 15, 2000 |
Last Updated: | September 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00006495 |
Health Authority: | United States: Federal Government |
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