June 27, 1999
| EARTH-1 (n) | EARTH-2 (n) | ||
| AZT + ddC (29) | AZT + 3TC (28) | ||
| AZT + ddI (32) | d4T + 3TC (34) | ||
| d4T + ddI (33) | d4T + 3TC + IDV (32) | ||
| d4T + 3TC + RTV (33) | No treatment (34) |
Only the d4T + 3TC + ritonavir (RTV) treatment arm showed changes in laboratory parameters, with increases in cholesterol and triglycerides. One patient in the group had a cholesterol level above normal, while the percentage of patients with abnormal triglycerides increased from 23% at baseline to 62% at follow up. Lipodystrophy was uncommon in the study; it was observed in only one patient receiving dual therapy and one patient receiving triple therapy.
The data suggest that disease state or length of infection may be associated with clinical lipodystrophy. It also indicates that RTV use may be involved in the elevation of triglycerides and cholesterol.