ASSESSMENT OF IGF-1 LEVELS IN HIV-INFECTED SUBJECTS AND USES THEREOF

1 . (canceled)

2 . A method for determining whether an HIV-infected subject has a normal insulin-like growth factor 1 (IGF-1) level, said method comprising:

(a) obtaining an IGF-1 value from a blood-derived sample from said HIV-infected subject; and

(b) determining an IGF-1 standard deviation score (SDS) based on said IGF-1 value, wherein said IGF-1 SDS is determined using the following equation:

IGF-1 SDS=( x −μ)/σ

in which

x is the log of said IGF-1 value;

μ is the mean of log of IGF-1 values obtained in blood-derived samples from a population of age- and gender-matched HIV-infected subjects; and

σ is the standard deviation of said log of IGF-1 values obtained in blood-derived samples from a population of age- and gender-matched HIV-infected subjects;

wherein an IGF-1 SDS determined by said equation that is ≧−z α or ≦z α is indicative that said HIV-infected subject has a normal IGF-1 level, and wherein an IGF-1 SDS determined by said equation that is <−z α or >z α is indicative that said HIV-infected subject has an abnormal IGF-1 level, wherein z α is from 1.282 to 5.0.

3 . (canceled)

4 . The method of claim 2 , wherein said log is log e .

5 . The method of claim 2 , wherein z α is 1.645, 1.96, 2.0, 2.5, 2.576 or 3.0.

6 - 10 . (canceled)

11 . The method of claim 2 , wherein said IGF-1 level is a serum IGF-1 level and said blood-derived sample is a serum sample.

12 . (canceled)

13 . A method for determining whether an HIV-infected subject has a normal insulin-like growth factor 1 (IGF-1) level, said method comprising:

(a) obtaining an IGF-1 value from a blood-derived sample from said HIV-infected subject;

(b) performing a log transformation of said IGF-1 value to obtain a log transformed IGF-1 value; and

(c) comparing said log transformed IGF-1 value to a log transformed normative range, wherein said log transformed normative range is determined using the following equation:

log transformed normative range=μ±( z α σ)

in which

μ is the mean of log A transformed IGF-1 values obtained in blood-derived samples from a population of age- and gender-matched HIV-infected subjects;

A is the base of log A ;

z α is from 1.282 to 5.0; and

σ is the standard deviation of said log A of IGF-1 values obtained in blood-derived samples from a population of age- and gender-matched HIV-infected subjects;

wherein a log A transformed IGF-1 value that is within said log A transformed normative range is indicative that said HIV-infected subject has a normal IGF-1 level, and a log A transformed IGF-1 value that is outside said log A transformed normative range is indicative that said HIV-infected subject has an abnormal IGF-1 level.

14 . (canceled)

15 . A method for determining whether an HIV-infected subject has a normal insulin-like growth factor 1 (IGF-1) level, said method comprising:

(a) obtaining an IGF-1 value from a blood-derived sample from said HIV-infected subject; and

(b) comparing said IGF-1 value to a normative range, wherein said normative range is determined using the following equation:

normative range= A (μ±( Z α ·σ))

in which

μ is the mean of log A transformed IGF-1 values obtained in blood-derived samples from a population of age- and gender-matched HIV-infected subjects;

A is the base of log A ;

z α is from 1.282 to 5.0; and

σ is the standard deviation of said log A of IGF-1 values obtained in blood-derived samples from a population of age- and gender-matched HIV-infected subjects;

wherein an IGF-1 value that is within said normative range is indicative that said HIV-infected subject has a normal IGF-1 level, and an IGF-1 value that is outside said normative range is indicative that said HIV-infected subject has an abnormal IGF-1 level.

16 . (canceled)

17 . The method of claim 15 , wherein A is e.

18 . The method of claim 13 , wherein z α is 1.645, 1.96, 2.0, 2.5, 2.576 or 3.0.

19 - 23 . (canceled)

24 . The method of claim 13 , wherein said IGF-1 level is serum IGF-1 level and said blood-derived sample is a serum sample.

25 . The method of claim 2 , wherein said HIV-infected subject suffers from lipodystrophy.

26 . The method of claim 2 , wherein said HIV-infected subject is undergoing a growth hormone stimulation therapy.

27 . A method for determining a normative range for the monitoring of insulin-like growth factor 1 (IGF-1) levels in HIV-infected subjects, said method comprising:

(a) obtaining IGF-1 values from blood-derived samples from a population of HIV-infected subjects;

(b) calculating said normative range in accordance with the following equation:

normative range= A (μ±( Z α·σ))

in which

μ is the mean of log A transformed IGF-1 values obtained in blood-derived samples from a population of HIV-infected subjects;

A is the base of log A ;

z α is from 1.282 to 5.0; and

σ is the standard deviation of said log A of IGF-1 values obtained in blood-derived samples from a population of HIV-infected subjects.

28 . (canceled)

29 . The method of claim 27 , wherein log A is log e .

30 . The method of claim 27 , wherein z α is 1.645, 1.96, 2.0, 2.5, 2.576 or 3.0.

31 - 35 . (canceled)

36 . The method of claim 27 , wherein said IGF-1 levels are serum IGF-1 levels and said blood-derived samples are serum samples.

37 . The method of claim 27 , wherein said HIV-infected subject suffers from lipodystrophy.

38 . (canceled)

39 . A method of monitoring GH stimulation therapy in an HIV-infected subject, comprising

(i) determining whether the subject exhibits a normal IGF-1 level using the method of claim 2 , wherein:

(a) a higher than normal IGF-1 level is indicative that the GH stimulation therapy is resulting in a GH level that is higher than a normal GH level;

(b) a lower than normal IGF-1 level is indicative that the GH stimulation therapy is resulting in a GH level that is lower than a normal GH level; and

(c) an IGF-1 level falling within a normative range is indicative that the GH stimulation therapy is resulting in a normal GH level; and

(ii) adjusting or modifying the GH stimulation therapy in the subject undergoing GH stimulation therapy in accordance with the determination of whether the subject exhibits a normal IGF-1 level.

40 . A method of determining whether GH stimulation therapy of an HIV subject should be adjusted or modified, comprising

(i) determining whether the subject exhibits a normal IGF-1 level using the method of claim 2 , wherein:

(a) a higher than normal IGF-1 level is indicative that the GH stimulation therapy should be reduced, interrupted or stopped;

(b) a lower than normal IGF-1 level is indicative that the GH stimulation therapy should be increased; and

(c) an IGF-1 level falling within a normative range is indicative that the GH stimulation therapy may be maintained without any significant adjustment;

(ii) adjusting or modifying the GH stimulation therapy in the subject undergoing GH stimulation therapy in accordance with the determination of whether the subject exhibits a normal IGF-1 level.

41 . (canceled)

42 . A program storage device readable by an electronic medium and tangibly storing instructions executable by the electronic medium to perform step (b) of the method of claim 2 and provide an indication as to whether the subject has a normal IGF-1 level.

43 . A computer program product comprising a computer useable medium that tangibly stores as computer readable code instructions to perform step (b) of the method of claim 2 and provide an indication as to whether the subject has a normal IGF-1 level.

44 - 47 . (canceled)