RITA - Spring - 2001Important note: Information in this article was accurate in Spring 2001. The state of the art may have changed since the publication date.
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Research Initiative Treatment Action (RITA!); Vol 7, No. 1 Spring 2001
 

Time and Events Schedule for the Main SMART Study

Note: This is an incomplete draft provided as a preliminary schema of the study schedule.

Please refer to the final CPCRA-approved protocol for the official schedule of events.

 

Requirement

Screening visit (within 45 days before
randomization)

Within 14 days before random-ization

Follow-up visits
Year 1
(Months)

Follow-up visits
Years 2-8
(Every 4 months)

 

1

2

4

6

8

10

12

4

8

12

Targeted health history, including HIV and supplemental diagnoses, clinical evaluation and concomitant treatments

X

 

X

X

X

X

X

X

X

X

X

X

AR treatment history

X

 

 

 

 

 

 

 

 

 

 

 

CD4 T cell count (determined locally)

X

 

X

X

X

X

X

X

X

X

X

X

Nadir CD4 T cell count available in the medical record

X

 

 

 

 

 

 

 

 

 

 

 

Plasma for HIV RNA level (determined locally)

X

 

X

X

X

X

X

X

X

X

X

X

Up to 3 most recent additional CD4 T cell counts and HIV RNA measurements available in the medical record

X

 

 

 

 

 

 

 

 

 

 

 

Documentation by laboratory report of hepatitis C antibody serostatus and hepatitis B serostatus

X

 

 

 

 

 

 

 

 

 

 

 

Blood sample (fasting or non-fasting) to determine: total cholesterol, LDL, HDL, VLDL cholesterol, triglycerides

X

 

 

 

 

 

 

 

X

 

 

X

Smoking status

X

 

 

 

 

 

 

 

X

 

 

X

Stored plasma sample for future HIV-related, CPCRA-approved research

X

 

 

 

 

 

 

 

X

 

 

X

Personal identifying information for ascertaining survival status (optional)

X

 

 

 

 

 

 

 

 

 

 

 

For women of childbearing potential, documented negative pregnancy test result on a specimen (serum or urine)

 

X

 

 

 

 

 

 

 

 

 

 

For women of child-bearing potential, self-reported pregnancy status

 

 

 

X

X

X

X

X

X

X

X

X

Current AR therapy and changes since last visit

 

 

 

X

X

X

X

X

X

X

X

X

Symptom severity

X

 

 

 

X

 

X

 

X

X

X

X

Changes in body appearance (patient self-report)

X

 

 

 

 

 

 

 

X

 

 

X

Plasma specimen for genotypic resistance testing

X

 

 

 

 

 

 

 

 

 

 

 

Stored plasma sample for future HIV drug resistance testing

X

 

 

X

X

X

X

X

X

X

X

X

Self-reported adherence to antiretroviral therapy (for patients who are currently prescribed AR therapy)

X

 

 

 

X

 

X

 

X

X

X

X

Demographic data

X

 

 

 

 

 

 

 

 

 

 

 

20010410
RI010408

Copyright © 2001 - Research Initiative Treatment Action (RITA!). Reproduced with permission. RITA! is published by The Center for AIDS. Contact Thomas Gegeny, MS, ELS, Editor, RITA! for permission to reproduce RITA!. tom@centerforaids.org. http://www.centerforaids.org

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