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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00001069 |
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.
Condition |
HIV Infections |
MedlinePlus related topics: | AIDS |
Study Type: | Observational |
Study Design: | Natural History |
Official Title: | A Randomized Study of the Clinical Effects of Initiating or Changing Antiretroviral Therapy Based on Plasma HIV RNA Quantitation Compared With Initiating or Changing Therapy Based on Current Clinical Practice Alone |
Estimated Enrollment: | 1100 |
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]).
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Patients with the following prior conditions are excluded:
United States, California | |||||
Community Consortium of San Francisco | |||||
San Francisco, California, United States, 94110 | |||||
United States, Colorado | |||||
Denver CPCRA / Denver Public Hlth | |||||
Denver, Colorado, United States, 802044507 | |||||
United States, District of Columbia | |||||
Veterans Administration Med Ctr / Regional AIDS Program | |||||
Washington, District of Columbia, United States, 20422 | |||||
United States, Georgia | |||||
AIDS Research Consortium of Atlanta | |||||
Atlanta, Georgia, United States, 30308 | |||||
United States, Illinois | |||||
AIDS Research Alliance - Chicago | |||||
Chicago, Illinois, United States, 60657 | |||||
United States, Louisiana | |||||
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med | |||||
New Orleans, Louisiana, United States, 70112 | |||||
United States, Maryland | |||||
Baltimore Trials | |||||
Baltimore, Maryland, United States, 21201 | |||||
United States, Michigan | |||||
Henry Ford Hosp | |||||
Detroit, Michigan, United States, 48202 | |||||
Comprehensive AIDS Alliance of Detroit | |||||
Detroit, Michigan, United States, 48201 | |||||
United States, New Jersey | |||||
North Jersey Community Research Initiative | |||||
Newark, New Jersey, United States, 071032842 | |||||
Southern New Jersey AIDS Cln Trials / Dept of Med | |||||
Camden, New Jersey, United States, 08103 | |||||
United States, New Mexico | |||||
Partners Research | |||||
Albuquerque, New Mexico, United States, 871315271 | |||||
United States, New York | |||||
Harlem AIDS Treatment Group / Harlem Hosp Ctr | |||||
New York, New York, United States, 10037 | |||||
United States, Oregon | |||||
Portland Veterans Adm Med Ctr / Rsch & Education Grp | |||||
Portland, Oregon, United States, 972109951 | |||||
The Research and Education Group | |||||
Portland, Oregon, United States, 97210 | |||||
United States, Pennsylvania | |||||
Philadelphia FIGHT | |||||
Philadelphia, Pennsylvania, United States, 19107 | |||||
United States, Virginia | |||||
Richmond AIDS Consortium | |||||
Richmond, Virginia, United States, 23298 |
Study Chair: | Thompson M | |
Study Chair: | Perez G |
Doepel LK. Volunteers needed for study of HIV viral load test. NIAID AIDS Agenda. 1995 Dec;:3. No abstract available.
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James JS. Viral load: new "strategy" trial in 15 U.S. cities. AIDS Treat News. 1995 Oct 20;(no 233):1-3. No abstract available.
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Raghavan S, Grant LB, Barisch G, Thompson M, Williams B, Matoe N, el-Sadr WM. Change in log10 HIV RNA and protease inhibitor use associated with weight change in HIV+ men in a national clinical trial. Int Conf AIDS. 1998;12:556 (abstract no 32180)
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Study ID Numbers: | CPCRA 036 |
First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00001069 |
Health Authority: | United States: Federal Government |
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