Table 1.
Baseline Characteristics of Study Subjects, by Response or Nonresponse to Tesamorelin
| Subjects Included in 26-Week Responder Analysis | Subjects Included in 52-Week Responder Analysis | |||||
|---|---|---|---|---|---|---|
| Responders | Nonresponders | Pa | Responders | Nonresponders | Pa | |
| Male sex, (%) | 87.5 | 84.8 | .509 | 86.4 | 83.3 | .644 |
| Age (years) | 47.6 ± 7.0 | 47.4 ± 7.7 | .770 | 48.3 ± 7.4 | 47.1 ± 7.6 | .348 |
| Race (%) | .466 | .418 | ||||
| White | 81.5 | 76.2 | 78.2 | 73.8 | ||
| Black | 9.9 | 13.3 | 14.5 | 11.9 | ||
| Other | 8.6 | 10.5 | 7.3 | 14.3 | ||
| Use of testosterone (%) | 21.1 | 20.0 | .712 | 23.6 | 23.8 | .893 |
| Use of lipid-lowering agents (%) | 46.6 | 42.9 | .596 | 45.5 | 38.1 | .395 |
| Current use of ART (%) | .190 | .101 | ||||
| NRTI + NNRTI and no PI | 34.1 | 43.8 | 30.9 | 50.0 | ||
| NRTI + NNRTI + PI | 9.1 | 9.5 | 10.9 | 7.1 | ||
| NRTI + PI and no NNRTI | 47.8 | 34.3 | 50.9 | 31.0 | ||
| NRTI alone | 3.9 | 5.7 | 4.6 | 4.8 | ||
| Other | 5.2 | 6.7 | 2.7 | 7.1 | ||
| CD4+ cell count (cells/mm3) | 609 ± 289 | 609 ± 279 | .895 | 607 ± 294 | 615 ± 261 | .963 |
| Undetectable viral load (%) | 77.6 | 72.1 | .177 | 75.5 | 73.8 | .91 |
| BMI | 28.4 ± 3.7 | 29.4 ± 4.7 | .033 | 28.5 ± 3.4 | 28.3 ± 4.5 | .698 |
| Presence of lipoatrophyb (%) | 73.7 | 68.6 | .380 | 70.9 | 78.6 | .371 |
| Waist circumference (cm) | 103.7 ± 8.6 | 106.1 ± 10.4 | .03 | 103.6 ± 8.2 | 102.8 ± 9.6 | .564 |
| VAT (cm2) | 187 ± 82 | 193 ± 84 | .67 | 190 ± 79 | 163 ± 70 | .08 |
| VAT:SAT | 1.28 ± 1.41 | 1.30 ± 1.35 | .886 | 1.34 ± 1.46 | 1.44 ± 1.58 | .724 |
| IGF-I level (ng/mL) | 152 ± 61 | 162 ± 66 | .11 | 163 ± 60 | 161 ± 79 | .849 |
Values are mean ± standard deviation, unless otherwise indicated.
Abbreviations: ART, antiretroviral therapy; BMI, body mass index (defined as the weight in kilograms divided by the height in meters squared); IGF-I, insulin-like growth factor-1; NNRTI, nonnucleoside reverse-transcriptase inhibitor; NRTI, nucleoside reverse-transcriptase inhibitor; PI, protease inhibitor; SAT, subcutaneous adipose tissue; VAT, visceral adipose tissue.
For comparison of values for responders with those for nonresponders at each time point. Analysis of variance modeling (controlling for study [first vs second phase III study]) was used for continuous variables, and the Cochran-Mantel-Haenszel statistic (controlling for study) was used for categorical variables, including viral load (detectable vs undetectable).
Defined as atrophy of the face and/or limbs, determined by the presence of ≥1 sign involving the face, lower limbs, or upper limbs.