- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00001069
A Study of Two Methods of Determining When to Begin or Change Anti-HIV Treatment
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
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.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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]).
Undersøgelsestype
Tilmelding
Kontakter og lokationer
Studiesteder
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California
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San Francisco, California, Forenede Stater, 94110
- Community Consortium of San Francisco
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Colorado
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Denver, Colorado, Forenede Stater, 802044507
- Denver CPCRA / Denver Public Hlth
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District of Columbia
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Washington, District of Columbia, Forenede Stater, 20422
- Veterans Administration Med Ctr / Regional AIDS Program
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Georgia
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Atlanta, Georgia, Forenede Stater, 30308
- AIDS Research Consortium of Atlanta
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Illinois
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Chicago, Illinois, Forenede Stater, 60657
- AIDS Research Alliance - Chicago
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Louisiana
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New Orleans, Louisiana, Forenede Stater, 70112
- Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
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Maryland
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Baltimore, Maryland, Forenede Stater, 21201
- Baltimore Trials
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Michigan
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Detroit, Michigan, Forenede Stater, 48202
- Henry Ford Hosp
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Detroit, Michigan, Forenede Stater, 48201
- Comprehensive AIDS Alliance of Detroit
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New Jersey
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Camden, New Jersey, Forenede Stater, 08103
- Southern New Jersey AIDS Cln Trials / Dept of Med
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Newark, New Jersey, Forenede Stater, 071032842
- North Jersey Community Research Initiative
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 871315271
- Partners Research
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New York
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New York, New York, Forenede Stater, 10037
- Harlem AIDS Treatment Group / Harlem Hosp Ctr
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Oregon
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Portland, Oregon, Forenede Stater, 97210
- The Research and Education Group
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Portland, Oregon, Forenede Stater, 972109951
- Portland Veterans Adm Med Ctr / Rsch & Education Grp
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19107
- Philadelphia FIGHT
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Virginia
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Richmond, Virginia, Forenede Stater, 23298
- Richmond AIDS Consortium
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Samarbejdspartnere og efterforskere
Efterforskere
- Studiestol: Perez G
- Studiestol: Thompson M
Publikationer og nyttige links
Generelle publikationer
- Doepel LK. Volunteers needed for study of HIV viral load test. NIAID AIDS Agenda. 1995 Dec:3.
- James JS. Viral load: new "strategy" trial in 15 U.S. cities. AIDS Treat News. 1995 Oct 20;(no 233):1-3.
- 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)
Datoer for undersøgelser
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CPCRA 036
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