Increased risk of lipoatrophy under stavudine in HIV-1-infected patients: results of a substudy from a comparative trial.
OBJECTIVE
To compare the incidence of clinical lipodystrophy in HIV-1-infected patients receiving zidovudine or stavudine, in combination with indinavir and lamivudine, in a randomized trial.


METHODS
NOVAVIR was a randomized multicentre trial comparing stavudine/lamivudine/indinavir and zidovudine/lamivudine/indinavir in 170 patients pretreated with zidovudine, didanosine or zalcitabine (> 6 months), but naive for lamivudine, stavudine and protease inhibitors. The incidence of clinical lipodystrophy and metabolic abnormalities was assessed in a subgroup of 101 patients after 30 months of follow-up.


RESULTS
The incidence of lipoatrophy was increased in the stavudine arm versus the zidovudine arm, as followed: facial atrophy: 48 versus 22% of patients, P = 0.011, lower limb atrophy: 49 versus 22% of patients, P = 0.006, buttock atrophy: 47 versus 20% of patients, P = 0.009, venomegaly: 57 versus 24% of patients, P = 0.001. There was no significant difference in the incidence of clinical signs of central fat accumulation nor in fasting metabolic parameters at month 30 between the two arms. In multivariate analyses, the stavudine arm, previous therapy with didanosine, and a lower CD4 cell count at study entry were associated with an increased risk of lipoatrophy, whereas older patients and women had an increased risk of lipohypertrophy.


CONCLUSIONS
Patients receiving stavudine/lamivudine/indinavir had a greater rate of clinical lipodystrophy, mainly lipoatrophy, than those treated with zidovudine/lamivudine/indinavir.
Joly
Véronique
V
Service de Maladies Infectieuses et Tropicales A, Hôpital Bichat Claude Bernard, 46 rue Henri Huchard, Paris, France. veronique.joly@bch.ap-hop-paris.fr
Flandre
Philippe
P
Meiffredy
Vincent
V
Leturque
Nicolas
N
Harel
Marine
M
Aboulker
Jean-Pierre
JP
Yeni
Patrick
P
D000328:Adult; D019380:Anti-HIV Agents / Q000009:adverse effects*; D023241:Antiretroviral Therapy, Highly Active / Q000009:adverse effects; D001824:Body Constitution; D015992:Body Mass Index; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000188:drug therapy*; D039682:HIV-Associated Lipodystrophy Syndrome / Q000139:chemically induced*; D006801:Humans; D019469:Indinavir / Q000009:adverse effects; D019259:Lamivudine / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D012307:Risk Factors; D018119:Stavudine / Q000009:adverse effects; D015215:Zidovudine / Q000009:adverse effects
D019380:Anti-HIV Agents; D019259:Lamivudine; D015215:Zidovudine; D019469:Indinavir; D018119:Stavudine