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Table 2: Follow up of subjects who are confirmed to have acute HIV infection (Continued)

Procedures

Wk 8

Wk 12

Wk 16

Wk 20

Wk1 24

Wk 36

Wk 48

Wk 60

Wk 72

Wk 84

Wk 96

Information sheet

/contact info

































Consent


































Counseling HIV results


































Updating and reviewing contact information

X

X

X

X

X

X

X

X

X

X

X

Routine EIA (6ml), sequential EIA/ pooled and/or individual NAT


































History, Risk behavior, PE

X

X

X

X

X

X

X

X

X

X

X

Questionnaires3













X




X




X




X

Neuropsychological test




X







X
















X

Neurological exam and psychiatric assessment




X







X
















X

HIV RNA (3ml)

X

X

X

X

X

X

X

X

X

X

X

CBC (1ml)

X

X

X

X

X

X

X

X

X

X

X

CD4, CD8 (2ml)

X

X

X

X

X

X

X

X

X

X

X

T/d bili, ALT, GGT) (2ml)




X







X




X




X




X

Creatinine (1ml)




X







X




X




X




X

TG, Chol, HDL, LDL (2ml)













X




X




X




X

Syphilis, HCV, HBV (3ml)


































Urine pregnancy test5




X







X

X

X

X

X

X

X

Urinalysis




X







X




X




X




X

CXR, EKG


































Brain MRI/MRS (optional)




X







X
















X

Plasma, PBMC







X

X




X




X

X

X




Leukopheresis and lymphocyte studies4

X

X4







X4




X4










X4

Urine collection

X

X







X




X




X




X

Genital secretion collection (optional)6




X







X




X




X




X

Cerebrospinal fluid collection (optional)7













X
















X

Colon biopsy (optional)













X
















X

Tracking/VCT of sexual contacts (optional)

X

X




























Blood volume (ml)8

6+50

9+50

6+40

6+40

11+50

6+45

11+50

6+45

11+40

6+45

11+50



Table 2: Follow up of subjects who are confirmed to have acute HIV infection (Continued)

Procedures

Wk 108

Wk 120

Wk 132

Wk 144

Wk 156

Wk 168

Wk 180

Wk 192/study end1,2

Information sheet

/contact info
























Consent

























Counseling HIV results

























Updating and reviewing contact information

X

X

X

X

X

X

X

X

Routine EIA (6ml), sequential EIA/ pooled and/or individual NAT

























History, Risk behavior, PE

X

X

X

X

X

X

X

X

Questionnaires3










X










X

Neuropsychological test










X










X

Neurological exam and psychiatric assessment










X










X

HIV RNA (3ml)

X

X

X

X

X

X

X

X

CBC (1ml)

X

X

X

X

X

X

X

X

CD4, CD8 (2ml)

X

X

X

X

X

X

X

X

T/d bili, ALT, GGT (2ml)




X




X




X




X

Creatinine (1ml)




X




X




X




X

TG, Chol, HDL, LDL (2ml)




X




X




X




X

Syphilis, HCV, HBV (3ml)

























Urine pregnancy test5

X

X

X

X

X

X

X

X

Urinalysis




X




X




X




X

CXR, EKG

























Brain MRI/MRS (optional)

























Plasma, PBMC

X

X

X

X

X

X

X

X

Leukopheresis and lymphocyte studies4

























Urine collection




X




X




X




X

Genital secretion collection (optional)6

























Cerebrospinal fluid collection (optional)7

























Colon biopsy (optional)

























Tracking/VCT of sexual contacts (optional)

























Blood volume (ml)8

6+40

11+40

6+40

11+40

6+40

11+40

6+40

11+40



1Study procedures for this visit may be performed on different days but preferably not more than 3 days apart. The subjects are encouraged to be hospitalized for the first 3-7 days. The visits for visit day 2 and 3 need to occur on the exact dates. Visits for day 5 to 10 may occur within ± 2 days of scheduled date. The window periods for other visits are as follows: ± 1 week for study weeks 2 and 4; ± 2 weeks for study weeks 8 to 24; ±4 weeks for all visits after week 24.

2The duration of follow up may vary among subjects depending on time of recruitment. Minimum time in study is 96 weeks and maximum time is 192 weeks. For subjects that the study duration is less than 192 weeks, procedures at week 192 will be done at the last study visit.

3Questionnaire on behavioral risk assessment. Demographic questionnaire will be used only for week 0 visit.

4Leukopheresis will be performed to collect PBMC and plasma in non-pregnant subjects. Subjects who wish not to have leukopheresis performed will undergo phlebotomy for PBMC/plasma collection. The amount of blood draw will be the same as blood loss from leukopheresis (50ml). Lymphocyte polyfunctional studies and immunophenotyping: the following lineage markers will be used for the immunophenotyping studies:CD16/56, CD19, CD3 (or Tetramer), CD4 and CD8. Differentiation markers will include CD27, CD28, CD45RA, CD45RO, CD57, CD95 and CCR7 and HLA-DR, CCR9 and alpha-4/beta-7 integrin. Additional markers for CD8+ T-cell effector activity will include IFNg, TNFa, IL-2, MIP1b, CD107 surface expression. Additional immunologic markers may be assessed depending on the scientific literature.

5Urine pregnancy test will be done at week 0, and every 12 weeks on females of child bearing age.

6Includes semen (male), cervicovaginal swab and washing (female), anal swab and washing (men who have sex with men)

7Blood glucose, protein and HIV RNA will be performed at time of lumbar puncture

8Total blood volume is shown. The first number is the blood volume for clinical follow up and the second number is the blood volume for stored samples. The total amount maximum volume of blood is 1267 ml over 4 years.

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