Progression of lipodystrophy (LD) with continued thymidine analogue usage: long-term follow-up from a randomized clinical trial (the PIILR study).

Publisher: Taylor & Francis Country of Publication: England NLM ID: 100936377 Publication Model: Print Cited Medium: Print ISSN: 1528-4336 (Print) Linking ISSN: 15284336 NLM ISO Abbreviation: HIV Clin Trials Subsets: MEDLINE

Publication: 2016-2018 : Abingdon : Taylor & Francis
Original Publication: St. Louis, MO : Thomas Land Publishers, c2000-

HIV Infections/*drug therapy ; HIV Protease Inhibitors/*administration & dosage ; HIV Protease Inhibitors/*adverse effects ; HIV-Associated Lipodystrophy Syndrome/*chemically induced; Abdomen/pathology ; Absorptiometry, Photon ; Adipose Tissue/diagnostic imaging ; Adipose Tissue/pathology ; Australia ; Body Composition ; CD4 Lymphocyte Count ; Cholesterol/blood ; Cholesterol, HDL/blood ; Cholesterol, LDL/blood ; Drug Administration Schedule ; Female ; HIV Protease Inhibitors/therapeutic use ; HIV-Associated Lipodystrophy Syndrome/diagnostic imaging ; HIV-Associated Lipodystrophy Syndrome/pathology ; Humans ; Insulin/blood ; Male ; Middle Aged ; Stavudine/administration & dosage ; Stavudine/adverse effects ; Stavudine/therapeutic use ; Tomography, X-Ray Computed ; Triglycerides/blood ; Viral Load ; Zidovudine/administration & dosage ; Zidovudine/adverse effects ; Zidovudine/therapeutic use

Purpose: During the 24-week PIILR study of protease inhibitor (PI) withdrawal, improved lipids and reduction in intraabdominal visceral fat was seen, however, there was also a loss of subcutaneous limb fat in patients with HIV-lipodystrophy (LD). It was hypothesized that overall improvement in LD may require a longer period of time off PIs.
Method: Follow-up of patients randomized to stop or continue PI-based therapy for 24 weeks, in a multicenter study, was continued for up to 120 weeks. Biochemistry and lipid parameters were assessed every 3 months. DEXA and CT scans were performed annually. Limb fat, visceral adipose tissue, and the lipodystrophy case definition score (LCDS) were used as indicators of LD severity.
Results: Forty-five male patients with baseline and week 120 body composition data were assessed. There were no significant changes in the limb fat or visceral adipose tissue (VAT) components of LD, with the exception of the LCDS (change from baseline +5.79, p < .001). Control of viral replication was maintained and lipid and glycemic parameters were unchanged over the 120-week follow-up. Linear regression analysis showed on-study usage of stavudine was independently and significantly correlated with both decreased limb fat mass and a higher LCDS.
Conclusion: Body composition or metabolic features of LD did not improve over 2 years of observation in patients remaining on predominantly PI-sparing therapy. LD was adversely influenced by continued stavudine use.

0 (Cholesterol, HDL)
0 (Cholesterol, LDL)
0 (HIV Protease Inhibitors)
0 (Insulin)
0 (Triglycerides)
4B9XT59T7S (Zidovudine)
97C5T2UQ7J (Cholesterol)
BO9LE4QFZF (Stavudine)

Date Created: 20041009 Date Completed: 20041201 Latest Revision: 20161124

20231215

10.1310/0GU7-6X27-MMHE-5ALE

15472793