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A Study of Two Methods of Determining When to Begin or Change Anti-HIV Treatment Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on A Study of Two Methods of Determining When to Begin or Change Anti-HIV Treatment conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Study of Two Methods of Determining When to Begin or Change Anti-HIV Treatment Clinical research trials and A Study of Two Methods of Determining When to Begin or Change Anti-HIV Treatment medical trials happen in hundreds of localities 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 typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like A Study of Two Methods of Determining When to Begin or Change Anti-HIV Treatment. A Study of Two Methods of Determining When to Begin or Change Anti-HIV Treatment Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a A Study of Two Methods of Determining When to Begin or Change Anti-HIV Treatment clinical trial. Participants frequently obtain the most expert healthcare available for their A Study of Two Methods of Determining When to Begin or Change Anti-HIV Treatment condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Study of Two Methods of Determining When to Begin or Change Anti-HIV Treatment  A Study of Two Methods of Determining When to Begin or Change Anti-HIV Treatment
A Study of Two Methods of Determining When to Begin or Change Anti-HIV Treatment
For Condition: HIV Infections
Status: Terminated
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: PRIMARY: To compare the clinical efficacy of two decision making strategies for initiating or changing antiretroviral therapy: decision making based on current clinical practice alone (i.e., initiating or changing therapy based on CD4 count decline and/or clinical progression) versus decision making based on plasma HIV RNA quantitation in addition to current clinical practice. SECONDARY: To evaluate toxicity, biological markers, and patient management in the two arms. Although changing therapies is a common strategy in the treatment of HIV disease, guidelines are needed to help clinicians and patients decide when a change in antiretroviral therapy is indicated. The technology of measuring HIV RNA in plasma has been suggested as a tool for monitoring clinical drug efficacy. However, uncertainty remains about whether aggressive antiretroviral treatment to lower HIV RNA and maintain low levels for as long as possible will confer clinical benefit in comparison with management based on monitoring CD4 counts and HIV-related symptoms.
Details: Although changing therapies is a common strategy in the treatment of HIV disease, guidelines are needed to help clinicians and patients decide when a change in antiretroviral therapy is indicated. The technology of measuring HIV RNA in plasma has been suggested as a tool for monitoring clinical drug efficacy. However, uncertainty remains about whether aggressive antiretroviral treatment to lower HIV RNA and maintain low levels for as long as possible will confer clinical benefit in comparison with management based on monitoring CD4 counts and HIV-related symptoms. Patients are randomized to a decision making strategy for initiating or changing therapy based on current clinical practice alone vs. decision making based on plasma HIV RNA quantitation in addition to current clinical practice in patients with <= 300 CD4+ cells/mm3. All patients in the RNA arm as well as a subset (n = 183) of those in the CCP arm will have a plasma HIV RNA quantitation drawn every 4 months. The results of these quantitations will be blinded until the end of the study. CD4 counts will be obtained at least every 4 months if the previous count was > 20 cells/mm3. The remaining patients in the CCP arm will have CD4 counts obtained according to their clinicians' current clinical practices. Medications, clinical status, and changes in antiretroviral therapy will be recorded for all patients in the study. Patients are stratified by CD4+ cell count (<100 cells/mm3 [200 patients] vs. 100-300 cells/mm3 [900 patients]).
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - HIV infection. - CD4 count <= 300 cells/mm3. - NO stage 2 or worse AIDS dementia complex. - Life expectancy of at least 6 months. - Reasonably good health. - age >= 13yrs. - signed informed consent. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Disorders or conditions that may prevent adequate compliance with study requirements. Patients with the following prior conditions are excluded: - Stage 2 >= AIDS dementia complex.
Total Enrollment: 1100
Location and Contact Information:
Overall Study Official:
ThompsonM, Study Chair,
Veterans Administration Med Ctr / Regional AIDS Program
Washington D.C., District of Columbia, 20422
United States
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York City, New York, 10037
United States
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, 70112
United States
Southern New Jersey AIDS Cln Trials / Dept of Med
Camden, New Jersey, 08103
United States
The Research and Education Group
Portland, Oregon, 97210
United States
Partners Research
Albuquerque, New Mexico, 871315271
United States
Comprehensive AIDS Alliance of Detroit
Detroit, Michigan, 48201
United States
Richmond AIDS Consortium
Richmond, Virginia, 23298
United States
Community Consortium of San Francisco
San Francisco, California, 94110
United States
North Jersey Community Research Initiative
Newark, New Jersey, 071032842
United States
Henry Ford Hosp
Detroit, Michigan, 48202
United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, 972109951
United States
Denver CPCRA / Denver Public Hlth
Denver, Colorado, 802044507
United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107
United States
Baltimore Trials
Baltimore, Maryland, 21201
United States
AIDS Research Alliance - Chicago
Chicago, Illinois, 60657
United States
Additional Information:
Study ID Numbers: CPCRA 036;
Study Start Date:
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001069
Other Hiv Infections Studies:
1. The Effects of r-metHuIFN-gamma on the Lungs of Patients with AIDS
2. Primary Prophylaxis of Cerebral Toxoplasmosis in HIV-Infected Patients
3. A Comparison of Two Caloric Supplements in the Prevention of Weight Loss in Patients with AIDS Who Take Daily Multivitamin and Mineral Supplements
4. A Randomized, Controlled Study of the Safety and Preventive Efficacy of Oral Ganciclovir When Used in Conjunction With An Intravitreal Ganciclovir Implant in the Treatment of Cytomegalovirus Retinitis
5. Drug Interactions of Amprenavir and Efavirenz, in Combination with a Second Protease Inhibitor, in HIV-Negative Volunteers
Related Studies:
Other HIV Infections Clinical Trials
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Other New Orleans Clinical Trials
A Study of Two Methods of Determining When to Begin or Change Anti-HIV Treatment
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