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Observing Patients with Early HIV Infection Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Observing Patients with Early HIV Infection conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Observing Patients with Early HIV Infection Clinical research trials and Observing Patients with Early HIV Infection healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Observing Patients with Early HIV Infection. Observing Patients with Early HIV Infection Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Observing Patients with Early HIV Infection clinical trial. Test subjects typically receive the most effective healthcare possible for their Observing Patients with Early HIV Infection condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "O" Clinical Trials Conditions > Observing Patients with Early HIV Infection  Observing Patients with Early HIV Infection
Observing Patients with Early HIV Infection
For Condition: HIV Infections
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to monitor patients who have recently been infected with HIV in order to learn how their immune systems respond to HIV infection and to study how the virus multiplies in their bodies. Patients who have been infected with HIV recently are considered to have acute, or early, HIV infection. During this period, viral load (level of HIV in the body) rises sharply to a high level at first but then decreases significantly on its own. Doctors are not sure why this decrease in viral load happens and how the body is able to accomplish this. In this study, patients with acute HIV infection will be monitored so that doctors can study their immune systems to try to learn more about this rise and fall in viral load.
Details: Two theories offer possible explanations for the early decline of viral loads seen in acute HIV infection. The first is that CD4 target cell numbers are depleted, so the reduction in permissive target cells limits viral replication. A second is that the host develops an HIV-specific cytotoxic T lymphocyte (CTL) immune response that limits viral replication during the initial high viral titer. Consequently, enhanced clearance of HIV-infected cells results in a decline of plasma HIV RNA. This study examines the latter theory by characterizing viral and immune dynamics in the blood and lymph nodes of HIV-infected patients. Cohort I (HIV-negative volunteers): At study entry a medical history and physical exam is performed, and volunteers complete a questionnaire. Blood samples are drawn weekly until Week 12, then at Weeks 14, 16, 20, and 24. Volunteers are followed for 24 weeks. Volunteers are offered the opportunity to participate in a lymphoid tissue substudy, which involves one to four sequential gut-associated lymphoid biopsies. Compensation for travel and for the inconvenience of study participation is provided. Cohort II: At study entry a patient history and physical exam is performed, and volunteers complete a questionnaire. Volunteers with a rising plasma HIV RNA during the first three visits will have frequent sampling of blood and physical exams for two years. Volunteers continue to be followed thereafter once every 6 months through 5 years of study duration. Volunteers are offered the opportunity to participate in a lymphoid tissue substudy and/or the lymphoid kinetics substudy. These substudies require hospitalizations of 24 hours or less for tissue biopsies and glucose infusion. Compensation for travel and for the inconvenience of study participation is provided
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Volunteers may be eligible for Cohort I of this study if they: - Are at least 13 years old (consent of parent or guardian required if under 18). - Have no active infections or cancer. - Are HIV-negative. Volunteers may be eligible for Cohort II of this study if they: - Are at least 13 years old (consent of parent or guardian required if under 18). - Have acute or early HIV infection. The stage of HIV infection will depend on the results of certain lab tests. - Agree not to take anti-HIV drugs the first 4 weeks of the study. Exclusion Criteria Volunteers will not be eligible for this study if they: - Weigh less than 45 kg (99 pounds). - Have begun anti-HIV therapy. - Are pregnant or breast-feeding.
Total Enrollment: 10
Location and Contact Information:
Overall Study Official:
SusanLittle, Principal Investigator,
Joanne Santangelo *Recruiting*
San Diego, California, 92103
United States
Recruiting
Additional Information:
Study ID Numbers: AIEDRP AI-05-008; AEHIV 008
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005020
Other Hiv Infections Studies:
1. A Study to Compare the Safety and Effectiveness of Two Dosing Schedules of Lamivudine in Combination with Two Other Anti-HIV Drugs
2. Directly Observed Therapy in HIV Infected Adolescent Focus Groups
3. Treatment Program for Anemia in AIDS Patients
4. Salvage Treatment, Resistance Testing, and Withdrawal of Anti-HIV Drugs for HIV Patients Failing Current Anti-HIV Treatment
5. Factors Affecting Adherence to Anti-HIV Drug Regimens in Children and Adolescents
Related Studies:
Other HIV Infections Clinical Trials
Other California Clinical Trials
Other San Diego Clinical Trials
Observing Patients with Early HIV Infection
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