Reversibility of lipoatrophy in HIV-infected patients 2 years after switching from a thymidine analogue to abacavir: the MITOX Extension Study.
OBJECTIVE
To determine if long-term improvement in HIV lipoatrophy can be attained by substitution of thymidine analogues zidovudine (ZDV) or stavudine (d4T) with abacavir (ABC).


METHODS
Long-term follow-up (104 weeks) of a randomized, open-label study.


METHODS
Seventeen ambulatory HIV clinics in Australia and London.


METHODS
Patients with HIV lipodystrophy were randomized to switch from a thymidine analogue to ABC, while continuing all other antiretroviral therapy (ABC arm) (n = 42) or continue current therapy (ZDV/d4T arm) (n = 43).


METHODS
At week 24, all control patients could switch to ABC. Of the original 111 patients randomized, 85 had long-term follow-up data, with 77 having imaging data available at 104 weeks.


METHODS
The primary endpoint was time-weighted change in limb fat mass, measured by dual-energy X-ray absorptiometry (DEXA).


RESULTS
At week 104, the mean increase in limb fat for the ABC and ZDV/d4T group was 1.26 +/- 2.02 kg and 0.49 +/- 1.38 kg, respectively. The time-weighted change for limb fat was significantly different between the two arms (0.43 kg; P = 0.008). On-treatment analysis demonstrated a trend for increased limb fat in patients in the ABC arm. Visceral fat accumulation, buffalo hump, self-assessed lipodystrophy or the lipodystrophy case definition score (LCDS) did not improve.


CONCLUSIONS
In patients with moderate-to-severe lipodystrophy, significant improvements in subcutaneous fat continued over 104 weeks after switching from a thymidine analogue to ABC. Nevertheless, the lipodystrophy syndrome was still evident, indicating additional strategies need evaluating.
Martin
Allison
A
National Centree in HIV Epidemiology and Clinical Research, University of New South Wales, Sydney, Australia.
Smith
Don E
DE
Carr
Andrew
A
Ringland
Clare
C
Amin
Janaki
J
Emery
Sean
S
Hoy
Jennifer
J
Workman
Cassy
C
Doong
Nicholas
N
Freund
Judith
J
Cooper
David A
DA
D015502:Absorptiometry, Photon; D000273:Adipose Tissue / Q000473:pathology; D019380:Anti-HIV Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001823:Body Composition / Q000187:drug effects; D015519:Bone Density / Q000187:drug effects; D015224:Dideoxynucleosides / Q000627:therapeutic use*; D005500:Follow-Up Studies; D015658:HIV Infections / Q000188:drug therapy; D039682:HIV-Associated Lipodystrophy Syndrome / Q000139:chemically induced* / Q000473:pathology; D006801:Humans; D018894:Reverse Transcriptase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D018119:Stavudine / Q000009:adverse effects / Q000627:therapeutic use; D015215:Zidovudine / Q000009:adverse effects / Q000627:therapeutic use; D000099227:Abacavir
D019380:Anti-HIV Agents; D015224:Dideoxynucleosides; D018894:Reverse Transcriptase Inhibitors; D018119:Stavudine; D015215:Zidovudine; D000099227:Abacavir