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Immune Responses in HIV-Positive Patients Receiving an Anti-HIV Drug Combination When Given the HIV Vaccines Remune and vCP1452 Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Immune Responses in HIV-Positive Patients Receiving an Anti-HIV Drug Combination When Given the HIV Vaccines Remune and vCP1452 conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Immune Responses in HIV-Positive Patients Receiving an Anti-HIV Drug Combination When Given the HIV Vaccines Remune and vCP1452 Clinical research trials and Immune Responses in HIV-Positive Patients Receiving an Anti-HIV Drug Combination When Given the HIV Vaccines Remune and vCP1452 health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Immune Responses in HIV-Positive Patients Receiving an Anti-HIV Drug Combination When Given the HIV Vaccines Remune and vCP1452. Immune Responses in HIV-Positive Patients Receiving an Anti-HIV Drug Combination When Given the HIV Vaccines Remune and vCP1452 Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Immune Responses in HIV-Positive Patients Receiving an Anti-HIV Drug Combination When Given the HIV Vaccines Remune and vCP1452 clinical trial. Human subjects often get the best healthcare possible for their Immune Responses in HIV-Positive Patients Receiving an Anti-HIV Drug Combination When Given the HIV Vaccines Remune and vCP1452 condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "I" Clinical Trials Conditions > Immune Responses in HIV-Positive Patients Receiving an Anti-HIV Drug Combination When Given the HIV Vaccines Remune and vCP1452  Immune Responses in HIV-Positive Patients Receiving an Anti-HIV Drug Combination When Given the HIV Vaccines Remune and vCP1452
Immune Responses in HIV-Positive Patients Receiving an Anti-HIV Drug Combination When Given the HIV Vaccines Remune and vCP1452
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for Step I of this study if they: - Are at least 18 years old. - Are HIV-infected. - Have been on stable anti-HIV combination drug therapy for at least 12 weeks prior to screening for viral load and are willing to continue the same treatment during the study unless they experience side effects from the drugs and have a viral load increase. - Have a viral load lower than 50 copies/ml at screening. Patients must have had a viral load below 500 copies/ml for at least 12 weeks prior to screening. - Have a CD4 T cell count of at least 300 cells/mm3 within 30 days prior to study entry. - Agree to practice acceptable methods of birth control, including male and female condoms, a diaphragm, or an intra-uterine device (IUD), while on study treatment and for 12 weeks after study treatment is discontinued. - Patients may be eligible for Step II of this study if they: - Are enrolled in A5058s under A5057/A5058s, Versions 1.0 and 2.0. Exclusion Criteria Patients will not be eligible for Step I of this study if they: - Are pregnant or breast-feeding. - Have an acute infection requiring antibiotics, an outbreak of a herpes virus, or other illness or surgery within 30 days prior to entry. - Have a long-term infection other than HIV. - Have cancer that may require systemic treatment. - Have had lymph node irradiation. - Have received any HIV vaccine. - Have used GM-CSF, G-CSF, M-CSF, IFN, IL-2, or similar medication within 30 days prior to entry. - Have used drugs affecting the immune system within 30 days prior to entry, or have an illness that may require use of these drugs. - Have had immunizations within 30 days prior to study entry. - Have received hydroxyurea within 30 days prior to study entry. - Are allergic to egg proteins or neomycin or have had other serious allergic reactions. - Work in close contact with canaries, or react to canarypox. Persons with a pet canary are not excluded. - Have had 2 viral load measurements in a row taken at least 14 days apart that were 500 copies/ml or higher in the 12 weeks prior to screening.
Total Enrollment: 80
Location and Contact Information:
Overall Study Official:
SpyrosKalams, Study Chair,
Wishard Hosp
Indianapolis, Indiana, 46202
United States
St Mary's Hosp (Univ of Rochester/Infectious Diseases)
Rochester, New York, 14642
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202
United States
Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Univ of Texas Galveston
Galveston, Texas, 775550435
United States
Boston Med Ctr
Boston, Massachusetts, 02118
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Community Health Network Inc
Rochester, New York, 14642
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
United States
Harbor UCLA Med Ctr
Torrance, California, 90502
United States
Brigham and Women's Hosp
Boston, Massachusetts, 02215
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
MetroHealth Med Ctr
Cleveland, Ohio, 441091998
United States
Additional Information:
Study ID Numbers: ACTG A5058s; AACTG A5058s
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006495
Other Hiv Infections Studies:
1. A Treatment Protocol for the Use of Intravenous Ganciclovir in AIDS Patients With Immediately Sight-Threatening CMV Retinitis
2. Garlic in hyperlipidemia caused by HAART
3. Active Immunization of Asymptomatic, HIV-Infected Individuals With Recombinant GP160 HIV-1 Antigen: A Phase I/II Study of Immunogenicity and Toxicity
4. A Randomized, Comparative Trial of Zidovudine (AZT) Versus 2',3'-Didehydro-3'-deoxythymidine (Stavudine; d4T) in Children With HIV Infection
5. A Trial of Alternating 2',3'-Dideoxycytidine and Zidovudine in the Treatment of Patients With Advanced HIV Disease
Related Studies:
Other HIV Infections Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Immune Responses in HIV-Positive Patients Receiving an Anti-HIV Drug Combination When Given the HIV Vaccines Remune and vCP1452
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