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.

                                   Screening visit    Within 14 days
                                   (within 45 days        before
                                       before         random-ization)
                                   randomization)

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

AR treatment history                      X

CD4 T cell count (determined              X
locally)

Nadir CD4 T cell count available          X
in the medical record

Plasma for HIV RNA level                  X
(determined locally)

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

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

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

Smoking status                            X

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

Personal identifying                      X
information for ascertaining
survival status (optional)

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

For women of childbearing
potential, self-reported
pregnancy status

Current AR therapy and changes
since last visit

Symptom severity                          X

Changes in body appearance                X
(patient self-report)

Plasma specimen for genotypic             X
resistance testing

Stored plasma sample for future           X
HIV drug resistance testing

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

Demographic data                          X

                                          Follow-up visits
                                           Year 1 (Months)

                                   1    2    4    6    8    10   12

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

AR treatment history               X    X    X    X    X    X    X

CD4 T cell count (determined       X    X    X    X    X    X    X
locally)

Nadir CD4 T cell count available
in the medical record

Plasma for HIV RNA level
(determined locally)

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

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

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

Smoking status                                                   X

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

Personal identifying
information for ascertaining
survival status (optional)

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

For women of childbearing               X    X    X    X    X    X
potential, self-reported
pregnancy status

Current AR therapy and changes          X    X    X    X    X    X
since last visit

Symptom severity                             X         X         X

Changes in body appearance                                       X
(patient self-report)

Plasma specimen for genotypic
resistance testing

Stored plasma sample for future         X    X    X    X    X    X
HIV drug resistance testing

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

Demographic data

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

                                         4     8     12

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

AR treatment history

CD4 T cell count (determined             X     X     X
locally)

Nadir CD4 T cell count available
in the medical record

Plasma for HIV RNA level                 X     X     X
(determined locally)

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

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

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

Smoking status                                       X

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

Personal identifying
information for ascertaining
survival status (optional)

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

For women of childbearing                X     X     X
potential, self-reported
pregnancy status

Current AR therapy and changes           X     X     X
since last visit

Symptom severity                         X     X     X

Changes in body appearance                           X
(patient self-report)

Plasma specimen for genotypic
resistance testing

Stored plasma sample for future          X     X     X
HIV drug resistance testing

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

Demographic data