Table 2.
Summary of outcome variables by treatment group; N, median(Q1, Q3)
| Outcome | NucleomaxX | Placebo | P-value |
|---|---|---|---|
| ITT, LOCF results: | |||
| Limb fat (g) change from baseline to week 48 | 75, 74(−206, 344) | 69, 110(−202, 393) | 0.64 |
| Limb fat (g) change from baseline to week 24 | 75, 54(−117, 315) | 66, 7(−202, 238) | 0.25 |
| Limb fat % change from baseline to week 48 | 75, 1.8(−6, 15) | 69, 4.1(−7.8, 13.4) | 0.99 |
| Limb fat % change from baseline to week 24 | 75, 2.7(−3.4, 12.4) | 66, 0.2(−7.3, 8.8) | 0.09 |
| Trunk fat (g) change from baseline to week 48 | 75, 274(−614,1065) | 69,550(−248,1296) | 0.09 |
| Trunk fat (g) change from baseline to week 24 | 75, 299(−379, 787) | 66, 330(−463, 923) | 0.62 |
| As-treated, completer results: | |||
| Limb fat (g) change from baseline to week 48 | 45, 74(−217, 231) | 46, 107(−247, 370) | 0.71 |
| Limb fat (g) change from baseline to week 24 | 48, 89(−65, 325) | 46, −36(−203, 144) | 0.01 |
| Limb fat % change from baseline to week 48 | 45, 1.8(−7.2, 11.5) | 46, 3.8(−7.8, 14.3) | 0.93 |
| Limb fat % change from baseline to week 24 | 48, 3.4(−2.4, 12.5) | 46, −0.8(−7.5, 6.5) | 0.01 |
| For at least 80% adherent subjects, LOCF results: | |||
| Limb fat % change from baseline to week 48 | 48, 3.9(−6.6, 13.7) | 45, 3.8(−7.8, 13.4) | 0.92 |
| Limb fat % change from baseline to week 24 | 48, 3.4(−2.4, 12.4) | 44, −0.8(−8.2, 7.8) | 0.01 |
| ITT, completer results: | |||
| HIV-1 RNA ≤50 cp/mL at week 48 | 59/67 (88%) | 54/69 (78%) | 0.17λ |
| CD4 cell count change from baseline to week 48 | 80, 33(−44, 90) | 80, 28(−43, 108) | 0.88 |
| Fasting lactate (mmol/L) change from baseline to week 48 | 67, 0.2(−0.2, 0.6) | 62, 0.1(−0.2, 0.4) | 0.60 |
| Fasting glucose (mg/dL) change from baseline to week 48 | 78, 2(−6, 9) | 78, 4(−5, 11) | 0.13 |
| Fasting total cholesterol (mg/dL) change from baseline to week 48 | 77, 2(−15, 22) | 75, −6(−22, 18) | 0.17 |
| Fasting triglycerides (mg/dL) change from baseline to week 48 | 77, −8(−29, 49) | 75, 13(−28, 62) | 0.43 |
| Fasting HDL (mg/dL) change from baseline to week 48 | 77, 1(−3, 4) | 73, −1(−6, 2) | 0.03 |
| Fasting LDL (mg/dL) change from baseline to week 48 | 67, 1(−12, 23) | 61, −3(−21, 15) | 0.10 |
| Fasting non-HDL (mg/dL) change from baseline to week 48 | 66, 2 (−13, 18) | 61, 2 (−18, 17) | 0.76 |
| Infraorbital fat- fold (mm) change from baseline to week 48 | 77, 0.3(−1, 2) | 74, 0.3(−0.7, 1) | 0.88 |
| Buccal fat-fold (mm) change from baseline to week 48 | 77, 0.3(−1, 1.3) | 74, 0(−0.7, 1.7) | 0.94 |
| Submandible fat-fold (mm) change from baseline to week 48 | 77, 0(−1, 1) | 74, 0.3(0, 1.3) | 0.06 |
P-value from stratified Wilcoxon rank sum test,
λ
P-value from Fisher’s exact test