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An Investigational Combination Vaccine Given to People Who Are Not Infected with HIV Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about An Investigational Combination Vaccine Given to People Who Are Not Infected with HIV conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. An Investigational Combination Vaccine Given to People Who Are Not Infected with HIV Clinical research trials and An Investigational Combination Vaccine Given to People Who Are Not Infected with HIV medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like An Investigational Combination Vaccine Given to People Who Are Not Infected with HIV. An Investigational Combination Vaccine Given to People Who Are Not Infected with HIV Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a An Investigational Combination Vaccine Given to People Who Are Not Infected with HIV clinical trial. Test subjects typically obtain the finest healthcare available for their An Investigational Combination Vaccine Given to People Who Are Not Infected with HIV condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > An Investigational Combination Vaccine Given to People Who Are Not Infected with HIV  An Investigational Combination Vaccine Given to People Who Are Not Infected with HIV
An Investigational Combination Vaccine Given to People Who Are Not Infected with HIV
For Condition: HIV Infections,HIV Seronegativity
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to see if the investigational vaccines NefTat and gp120w61d are safe and tolerable in humans and to see how the immune system responds to the vaccines. There have been advances in the treatment and prevention of HIV, but the spread of HIV/AIDS is getting worse. HIV/AIDS is the main infectious cause of death in the world. A vaccine to prevent HIV disease is the best way to try to deal with this situation. Several vaccine products have been tested, but only 2 are still in trial. There is a need for a new product.
Details: Despite recent advances in the treatment and prevention of HIV disease, the epidemic is worsening throughout most of the world. HIV/AIDS is the leading cause of death in sub-Saharan Africa and the leading infectious cause of death in the world. An effective and inexpensive vaccine to prevent HIV disease remains as the best option to try to deal with this expanding epidemic. A number of vaccine products have been tested; however, only 2 have progressed to a Phase III trial, underscoring the need for new vaccine strategies. Prior to study entry, participants have their risk status for HIV infection determined by a series of questions. Further eligibility is determined by results of physical exam, laboratory tests, and further questions. Blood is drawn on each study visit. Participants are assigned randomly to 1 of 4 study groups: Group I: NefTat or placebo. Groups II, III, and IV: NefTat and gp120 or placebo. Each group receives a different concentration of gp120. All immunizations are admixed with AS02A adjuvant. Vaccinations are administered intramuscularly at 3 time points (entry, 1 month, and 3 months). Product safety and immunogenicity are performed at designated time points; participants have about 11 clinic visits.
Eligibility:
Study Type: Interventional, Prevention, Double-Blind, Safety Study
Minimum Age/Maximum Age: 18 Years/60 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Participants may be eligible for this study if they: - Are between 18 and 60 years of age. - Are in good general health and meet laboratory test requirements. - Have a CD4 count of 400 or more cells/mm3. - Agree to use at least 1 of the following methods of contraception for at least 21 days before enrollment until the last protocol visit: condoms (male or female) with or without a spermicide, diaphragm or cervical cap with spermicide, IUD, or hormonal-based therapy (applies to women who are able to have children). - Have access to a participating site and are willing to have follow-up for the entire study (12 months). - Answer questions about their understanding of the study. - Do not have hepatitis B or C. - Are HIV-uninfected. Exclusion Criteria Participants may not be eligible for this study if they: - Are pregnant or breast-feeding. - Have recently received a vaccine. - Have used experimental agents within 30 days before enrollment. - Have received HIV vaccines or placebo in a previous HIV vaccine study. - Have received blood products 120 days before HIV screening. - Have received immunoglobulin (antibodies) 60 days before HIV screening. - Have serious reactions to vaccines. - Have problems with their immune system. - Have cancer. - Have used drugs that affect the immune system within the past 6 months. - Have diabetes. - Have a thyroid disease. - Have unstable asthma. - Are taking anti-tuberculosis drugs. - Have seizures. - Have a bleeding disorder. - Have had their spleen removed. - Have angioedema (a certain type of body tissue swelling). - Have active syphilis. - Have high blood pressure (unless controlled by medication). - Have mental or emotional problems that make them unsuitable for the study. - Have any medical, mental, or social condition; job responsibilities; or other responsibility that, in the opinion of the doctor, would interfere with the study. - Have reactions to components of the vaccines. - Are at high risk for contracting HIV.
Total Enrollment: 84
Location and Contact Information:
Overall Study Official:
TomEvans, Study Chair,
Vanderbilt Univ Hosp
Nashville, Tennessee, 37232
United States
Saint Louis University School of Medicine
St. Louis, Missouri, 63110
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Vanderbilt Univ / Med Ctr North
Nashville, Tennessee, 37232
United States
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, 21205
United States
Harvard University / Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
New York Blood Center
New York City, New York, 10021
United States
Miriam Hosp
Providence, Rhode Island, 02906
United States
San Francisco Dept of Hlth / AIDS Office
San Francisco, California, 94102
United States
Fenway Community Health
Boston, Massachusetts, 02115
United States
Mt Zion Hospital
San Francisco, California, 94102
United States
Univ of Rochester Med Ctr
Rochester, New York, 14642
United States
JHU-CIR/DC
Baltimore, Maryland, 21205
United States
Columbia Univ
New York City, New York, 10032
United States
Univ of Marlyand / Infectious Diseases Physicians
Fairfax, Virginia,
United States
Johns Hopkins Bloomberg School of Public Health
Washington D.C., District of Columbia, 20037
United States
Univ of Maryland Institute of Human Virology
Baltimore, Maryland, 212011192
United States
Harvard University/Brown University
Boston, Massachusetts, 02115
United States
Fred Hutchinson Cancer Research Ctr
Seattle, Washington, 98109
United States
New York Blood Ctr
Bronx, New York, 10456
United States
Additional Information:
Study ID Numbers: HVTN 041;
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00027365
Other Hiv Infections Studies:
1. Effectiveness of Anti-HIV Drugs in Patients Who Have Not Received Previous Anti-HIV Drugs During Different Stages of HIV Infection
2. A Study of Retrovir in the Treatment of Psoriasis in HIV-Positive Patients
3. Safety and Effectiveness of Giving Indinavir, Ritonavir, Stavudine, and Lamivudine to HIV-Infected Patients Who Have Never Received Anti-HIV Drugs
4. Effects of Giving Interleukin-2 (IL-2) Plus Anti-HIV Therapy to HIV-Positive Patients with CD4 Cell Counts of at Least 350 Cells/mm3
5. Phase I Pharmacokinetic and Tolerance Study of Ribavirin in Human Immunodeficiency Virus (HIV) - Infected Patients
Related Studies:
Other HIV Infections Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
An Investigational Combination Vaccine Given to People Who Are Not Infected with HIV
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