|
The Effects of Illnesses on HIV Levels in the Body 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 The Effects of Illnesses on HIV Levels in the Body conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. The Effects of Illnesses on HIV Levels in the Body Clinical research trials and The Effects of Illnesses on HIV Levels in the Body 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 The Effects of Illnesses on HIV Levels in the Body. The Effects of Illnesses on HIV Levels in the Body 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 The Effects of Illnesses on HIV Levels in the Body clinical trial. Test subjects typically obtain the finest healthcare available for their The Effects of Illnesses on HIV Levels in the Body 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.
|
|
|
|
|
|
|
Home > "T" Clinical Trials Conditions > The Effects of Illnesses on HIV Levels in the Body  The Effects of Illnesses on HIV Levels in the Body
The Effects of Illnesses on HIV Levels in the Body
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To describe the magnitude and duration of changes in HIV-1 RNA levels during and after an acute febrile illness. To identify factors associated with increases, i.e., type of illness ultimately diagnosed (bacterial, viral, fungal), CD4 cell count, and antiretroviral treatment regimen. To describe changes in phenotypic markers of immune activation/dysregulation of CD4 and CD8 lymphocyte subsets and their relationship to intercurrent illness. To describe changes in plasma cytokines and soluble activation markers and their relationship to plasma HIV-1 viremia during and after the onset of intercurrent illness. To characterize the viral biologic phenotype and the viral drug susceptibility genotype before, during, and after the onset of an acute febrile illness. To characterize the expression of HIV-1 co-receptors before, during, and after the onset of an acute febrile illness Repeated episodes of intercurrent infections have been postulated to be an important stimulus for progression of HIV infection. The study of intercurrent illness in patients with initially undetectable viral load removes viral load as a possible cause for virologic and immunologic changes and allows for a more direct association of the intercurrent illness with changes in viral load, viral HIV-1 phenotypes, viral HIV-1 genotypes, and T cell phenotypes. Studying intercurrent illness and viral load provides an opportunity to characterize the potentially dynamic changes not only in viral load but also in phenotypic markers of T cell activation, plasma cytokine levels, phenotypic and genotypic changes in circulating virus, and HIV-1 tropisms.
Details: Repeated episodes of intercurrent infections have been postulated to be an important stimulus for progression of HIV infection. The study of intercurrent illness in patients with initially undetectable viral load removes viral load as a possible cause for virologic and immunologic changes and allows for a more direct association of the intercurrent illness with changes in viral load, viral HIV-1 phenotypes, viral HIV-1 genotypes, and T cell phenotypes. Studying intercurrent illness and viral load provides an opportunity to characterize the potentially dynamic changes not only in viral load but also in phenotypic markers of T cell activation, plasma cytokine levels, phenotypic and genotypic changes in circulating virus, and HIV-1 tropisms. This is a study to determine whether patients exhibit a temporary burst of viral replication or other changes in response to intercurrent febrile illness. Although there is no study treatment, patients on this study must be co-enrolled in at least 1 other ACTG antiretroviral treatment study. Plasma HIV-1 RNA and other variables are measured at the time of presentation, on Day 3, and at Weeks 1, 2, 4, 8, 16, and 24.
Eligibility:
Study Type: Observational, Natural History, Longitudinal
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - HIV-1 infection documented by any licensed ELISA test kit and confirmed by either Western blot, HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA or a second antibody test by a method other than ELISA at any time prior to study entry. - Undetectable plasma HIV-1 RNA (by Roche Amplicor Assay) within 8 weeks prior to study entry. - Documented temperature above 101degrees F during at least 1 of the 2 days prior to the day of screening and present on the day of screening, or documented temperature above 101 F on the day of the screening but no fever on 1 of the 2 days prior to screening. [AS PER AMENDMENT 7/7/98: - Documented temperature above 101degrees F on the day of the screening.] - Co-enrollment in at least 1 other ACTG antiretroviral treatment study (NOTE: - Co-enrollment is approved and encouraged with the following ACTG studies: - 343, 347, 359, 368, 370, and 372). [AS PER AMENDMENT 7/7/98: Must be enrolled in either an ACTG antiretroviral therapy study or a pharmaceutical company-sponsored antiretroviral therapy study prior to entry. Co-enrolled in a non-ACTG pharmaceutical company-based study must have a baseline viral isolate accessible for use in this study.] - Written informed consent of a parent or guardian if under 18 years of age. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Interruption of current antiretroviral therapy due to the onset of acute intercurrent illness. Concurrent Medication: Excluded: - Patients receiving IL-2. Patients with the following prior conditions are excluded: - Change in antiretroviral therapy combination within 8 weeks prior to study entry. Required: - Concurrent enrollment in an ACTG antiretroviral therapy study [or, AS PER AMENDMENT 7/7/98, in a non-ACTG pharmaceutical company-sponsored antiretroviral treatment study]. - Stable antiretroviral and/or nucleoside analog therapy for 8 weeks prior to study entry.
Total Enrollment: 26
Location and Contact Information:
Overall Study Official:
ShaB, Study Chair,
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Univ of Hawaii
Honolulu, Hawaii, 96816
United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Queens Med Ctr
Honolulu, Hawaii, 96816
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Howard Univ
Washington D.C., District of Columbia, 20059
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St. Louis, Missouri, 63112
United States
Univ of Nebraska Med Ctr
Omaha, Nebraska, 681985130
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Additional Information:
Study ID Numbers: ACTG 891;
Study Start Date:
Record last reviewed: April 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000900
Other Hiv Infections Studies:
1. A Study of LXR015-1 in HIV-Infected Patients
2. A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 100 mcg of Env 2-3 in MF59
3. The Effects of Anti-HIV Drugs on the HIV Virus in HIV-Infected Patients
4. Interactions Between HIV Protease Inhibitors and Calcium Channel Blockers
5. A Phase II Clinical Trial to Evaluate the Immunogenicity and Reactogenicity of the Recombinant HIV-1 Envelope Vaccines SF-2 rgp120 (CHO) [Chiron Vaccines] in MF59 Adjuvant and MN rgp120/HIV-1 [VaxGen] in Alum Adjuvant in Healthy Adults
Related Studies:
Other HIV Infections Clinical Trials
Other Hawaii Clinical Trials
Other Honolulu Clinical Trials
The Effects of Illnesses on HIV Levels in the Body
|
|
|
|
|
|
|
|
