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| Tracking Information | |||||||||
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| First Received Date ICMJE | November 2, 1999 | ||||||||
| Last Updated Date | July 29, 2008 | ||||||||
| Start Date ICMJE | |||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00000943 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | A Study to Test If Giving Remune (an HIV Vaccine) Can Improve the Immune Systems of HIV-Positive Patients Who Are Also Participating in ACTG 328 | ||||||||
| Official Title ICMJE | A Controlled, Pilot Study of the Immunogenicity of Remune in HIV-Infected Subjects Receiving Either Highly Active Antiretroviral Therapy (HAART) Alone or HAART and Interleukin-2 (IL-2): A Nested Substudy of ACTG 328 | ||||||||
| Brief Summary | The purpose of this study is to determine the effects of an HIV vaccine (Remune) on the immune system. This study involves patients who have received at least 60 weeks of anti-HIV therapy, either alone or in combination with IL-2, while enrolled in ACTG 328. Remune is an experimental HIV vaccine. To see how the body's immune system reacts, this vaccine will be given with 1 to 3 other vaccines, and skin tests will monitor the body's reaction. |
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| Detailed Description | Proliferative responses to HIV antigens are either absent or of small magnitude in HIV-infected patients, even in the early stages of infection when vigorous proliferative responses to recall antigens are still seen. Remune consists of an inactivated, gp120-depleted virus intended to stimulate HIV-specific immune responses. Remune has been reported to increase lymphocyte proliferative responses to HIV antigens in patients with high CD4 cell counts. Many other T-cell-dependent responses are also impaired in HIV-infected patients, such as after vaccination with hepatitis A or B vaccine. In this study, patients with moderately advanced HIV disease who have already received 52 weeks of either HAART or HAART plus IL-2 are vaccinated with Remune and a control recall immunogen, tetanus toxoid (TT), to evaluate whether these patients can develop new CD4 T-cell and CD8 T-cell responses to HIV-related antigens. The antibody response to hepatitis A and hepatitis B vaccinations also will be explored. Fifty patients are enrolled in this substudy; 17 from the HAART only arm (Arm I of ACTG 328) and 33 from the HAART plus either CIV or subcutaneous IL-2 arms (Arms II and III of ACTG 328). All patients are vaccinated 3 times with Remune and twice with TT. If patients are hepatitis A total antibody negative, they receive hepatitis A vaccine twice. Additionally, if patients are hepatitis B surface antigen negative, hepatitis B core antibody and surface antibody negative, they receive hepatitis B vaccine 3 times. Patients who are negative for all hepatitis markers receive hepatitis A and B vaccines. Week 0 of A5046s begins at or after Week 64 of ACTG 328 (for patients in the HAART-only arm) or 4 weeks after the initiation of the seventh or any subsequent IL-2 cycle of ACTG 328 (for patients in any of the IL-2-containing arms). [AS PER AMENDMENT 9/16/99: Patients can be screened through Week 124 of ACTG 328.] Patients receive Remune at Weeks 0, 8, and 16 and TT at Weeks 0 and 8. Hepatitis A and/or B vaccines are also given at these times, if indicated. Blood and skin tests are performed at Weeks 0, 8, 16, and 24 to measure immune response and lymphocyte proliferative responses. |
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| Study Phase | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Placebo Control | ||||||||
| Condition ICMJE | HIV Infections | ||||||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||||||
| Publications * | Valdez H, Mitsuyasu R, Landay A, Sevin AD, Chan ES, Spritzler J, Kalams SA, Pollard RB, Fahey J, Fox L, Namkung A, Estep S, Moss R, Sahner D, Lederman MM. Interleukin-2 Increases CD4+ Lymphocyte Numbers but Does Not Enhance Responses to Immunization: Results of A5046s. J Infect Dis. 2003 Jan 15;187(2):320-5. | ||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 50 | ||||||||
| Completion Date | |||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria Patients may be eligible for this study if they:
Exclusion Criteria Patients will not be eligible for this study if they:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00000943 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | ACTG A5046s, ACTG 328 (Main Study), AACTG A5046s | ||||||||
| Study Sponsor ICMJE | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||
| Verification Date | June 2003 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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