A Study of Two Methods of Determining When to Begin or Change Anti-HIV Treatment
- Conditions
- HIV Infections
- Registration Number
- NCT00001069
- Brief Summary
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.
- Detailed Description
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 \[900 patients\]).
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1100
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (17)
Community Consortium of San Francisco
🇺🇸San Francisco, California, United States
Veterans Administration Med Ctr / Regional AIDS Program
🇺🇸Washington, District of Columbia, United States
The Research and Education Group
🇺🇸Portland, Oregon, United States
AIDS Research Alliance - Chicago
🇺🇸Chicago, Illinois, United States
Southern New Jersey AIDS Cln Trials / Dept of Med
🇺🇸Camden, New Jersey, United States
Philadelphia FIGHT
🇺🇸Philadelphia, Pennsylvania, United States
AIDS Research Consortium of Atlanta
🇺🇸Atlanta, Georgia, United States
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
🇺🇸New Orleans, Louisiana, United States
Baltimore Trials
🇺🇸Baltimore, Maryland, United States
Richmond AIDS Consortium
🇺🇸Richmond, Virginia, United States
Harlem AIDS Treatment Group / Harlem Hosp Ctr
🇺🇸New York, New York, United States
Henry Ford Hosp
🇺🇸Detroit, Michigan, United States
Denver CPCRA / Denver Public Hlth
🇺🇸Denver, Colorado, United States
Partners Research
🇺🇸Albuquerque, New Mexico, United States
North Jersey Community Research Initiative
🇺🇸Newark, New Jersey, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
🇺🇸Portland, Oregon, United States
Comprehensive AIDS Alliance of Detroit
🇺🇸Detroit, Michigan, United States