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A Study of LIPO-5 and ALVAC-HIV (vCP1452) as Possible HIV Vaccines Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about A Study of LIPO-5 and ALVAC-HIV (vCP1452) as Possible HIV Vaccines conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Study of LIPO-5 and ALVAC-HIV (vCP1452) as Possible HIV Vaccines Clinical research trials and A Study of LIPO-5 and ALVAC-HIV (vCP1452) as Possible HIV Vaccines health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as A Study of LIPO-5 and ALVAC-HIV (vCP1452) as Possible HIV Vaccines. A Study of LIPO-5 and ALVAC-HIV (vCP1452) as Possible HIV Vaccines Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a A Study of LIPO-5 and ALVAC-HIV (vCP1452) as Possible HIV Vaccines clinical trial. Human subjects frequently get the finest healthcare available for their A Study of LIPO-5 and ALVAC-HIV (vCP1452) as Possible HIV Vaccines condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Study of LIPO-5 and ALVAC-HIV (vCP1452) as Possible HIV Vaccines  A Study of LIPO-5 and ALVAC-HIV (vCP1452) as Possible HIV Vaccines
A Study of LIPO-5 and ALVAC-HIV (vCP1452) as Possible HIV Vaccines
For Condition: HIV Infections,HIV Seronegativity
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Agence Nationale de Recherche sur le SIDA (ANRS), France
Synopsis: This study will test the immune system response to and safety of two HIV vaccines alone and in combination: ALVAC-HIV (vCP1452) and LIPO-5. ALVAC-HIV (vCP1452) uses a canarypox virus with man-made parts of HIV attached to it. The canarypox virus cannot cause disease in people. LIPO-5 is a mixture of five man-made proteins similar to proteins found in HIV. These vaccines are not produced from live HIV or from infected cells and do not contain the virus. It is not possible to become infected with HIV from these vaccines.
Details: Immune priming of cytotoxic T lymphocytes (CTLs) has been most successfully achieved with live attenuated virus or live virus vector vaccines. Recombinant canarypox vaccines have an excellent safety record and have induced HIV neutralizing antibodies and CTLs in early clinical trials. This study will evaluate the use of HIV lipopeptides (LIPO-5) alone and in combination with a canarypox-based HIV vaccine [ALVAC-HIV (vCP1452)] to further increase CTL activity. Participants in this study will be randomly assigned to one of five groups. Participants in Groups A and B will receive four injections over 6 months. Participants in Group A will receive four injections of either LIPO-5 or a placebo. Participants in Group B will receive four injections of either the ALVAC-HIV (vCP1452) or a placebo. Participants in Groups C, D, and E will receive six injections over 6 months. Participants in these groups will receive either ALVAC-HIV (vCP1452) and LIPO-5 or a placebo. Participants who receive the vaccine combination will receive four injections of the same dose of ALVAC-HIV (vCP1452) and two injections of LIPO-5. The dose of LIPO-5 will be different for participants in Groups C, D, and E. Participants will have 11 study visits over 18 months. The length of visits will vary and may last up to 3 hours. Study visits will include a medical interview, brief physical exam, and blood and urine tests. Participants will be tested for HIV before entering the study and at least five times during the study. All vaccine and placebo injections will be given in the upper arm muscle.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety Study
Minimum Age/Maximum Age: 18 Years/50 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - HIV uninfected - Willing to receive HIV test results - Good general health - Acceptable methods of contraception for females of reproductive potential - Access to participating site and available for follow-up during the study Exclusion Criteria: - HIV vaccines or placebos in prior HIV vaccine trial - Immunosuppressive medications within 168 days prior to first study vaccine administration - Blood products within 120 days prior to first study vaccine administration - Immunoglobulin within 60 days prior to first study vaccine administration - Live attenuated vaccines within 30 days prior to first study vaccine administration - Investigational research agents within 30 days prior to first study vaccine administration - Subunit or killed vaccines within 14 days prior to first study vaccine administration - Current tuberculosis prophylaxis or therapy - Hypersensitivity to neomycin or egg products - Uveitis, chronic Lyme disease, active mycobacterial diseases, or sarcoidosis - Serious adverse reaction to a vaccine. A person who had an adverse reaction to pertussis vaccine as a child is not excluded. - Autoimmune disease or immunodeficiency - Active syphilis - Unstable asthma - Type 1 or Type 2 diabetes mellitus - Thyroid disease requiring treatment in the past 12 months - Serious angioedema within the past 3 years - Uncontrolled hypertension - Bleeding disorder - Malignancy unless it has been surgically removed and, in the opinion of the investigator, is not likely to recur during the study period - Seizure disorder requiring medication within the past 3 years - Asplenia - Mental illness that would interfere with compliance with the protocol - Other conditions that, in the judgment of the investigator, would interfere with the study - Pregnant or breast-feeding
Total Enrollment: 174
Location and Contact Information:
Overall Study Official:
LarryPeiperl, Study Chair, San Francisco Dept. of Public Health
Miriam Hospital *Recruiting*
Providence, Rhode Island, 02906
United States
Recruiting Melissa DiSpigno 401-793-4932
FHCRC/UW - Vaccine Trial Unit *Not yet recruiting*
Seattle, Washington, 98104
United States
Not yet recruiting David Berger 206-667-2344
University of Alabama at Birmingham *Recruiting*
Birmingham, Alabama, 35294-2041
United States
Recruiting Susan Duncan 205-975-2840
New York Blood Center - Union Square *Not yet recruiting*
New York City, New York, 10003
United States
Not yet recruiting Kent Curtis 212-388-0008
University of Rochester *Not yet recruiting*
Rochester, New York, 14642-0001
United States
Not yet recruiting Catherine Bunce 585-275-5744
Harvard Medical School/Brigham & Womens Hospital *Not yet recruiting*
Boston, Massachusetts, 02115
United States
Not yet recruiting Kristen Whiteside 617-525-6778
JHU-CIR/DC *Not yet recruiting*
Baltimore, Maryland, 21205-1901
United States
Not yet recruiting Eric Zimmerman 410-955-7283
New York Blood Center - Bronx *Not yet recruiting*
Bronx, New York, 10456
United States
Not yet recruiting Pamela Brown-Peterside 718-588-8900
University of MD - Inst. of Human Virology (IHV) *Recruiting*
Baltimore, Maryland, 21201-1192
United States
Recruiting Lynda Nerhood 410-706-1291
St. Louis University - New Hope Bldg *Recruiting*
St. Louis, Missouri, 63110-2500
United States
Recruiting Heidi Israel 314-268-5448
Vanderbilt University *Not yet recruiting*
Nashville, Tennessee, 37232
United States
Not yet recruiting Kyle Rybczyk 615-322-5641
Johns Hopkins University *Not yet recruiting*
Baltimore, Maryland, 21205-1901
United States
Not yet recruiting Eric Zimmerman 410-955-7283
Additional Information:
Study ID Numbers: HVTN 042; ANRS VAC019
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00076063
Other Hiv Infections Studies:
1. A Phase I Study of AZT and Human Interferon Alpha (Recombinant Alpha-2A and Lymphoblastoid) in the Treatment of AIDS-Associated Kaposi's Sarcoma
2. Safety and Effectiveness of Giving Isotretinoin to HIV-Infected Women to Treat Cervical Tumors
3. The Safety and Effectiveness of Clarithromycin in the Prevention of Mycobacterium avium Complex (MAC) Infection in HIV-Infected Patients
4. A Study to Test the Safety, Tolerance, and Metabolism of Abacavir (1592U89, ABC) With Standard Zidovudine (ZDV) Therapy in Newborn Infants Born to HIV-1 Infected Women
5. Effectiveness of Giving an HIV Vaccine (Remune) to HIV-Positive Patients Receiving an Anti-HIV Drug Combination
Related Studies:
Other HIV Infections Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
A Study of LIPO-5 and ALVAC-HIV (vCP1452) as Possible HIV Vaccines
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