CD4-guided structured antiretroviral treatment interruption strategy in HIV-infected adults in west Africa (Trivacan ANRS 1269 trial): a randomised trial.
BACKGROUND
Structured treatment interruptions of highly-active antiretroviral therapy (HAART) might be particularly relevant for sub-Saharan Africa, where cost-saving strategies could help to increase the number of patients on HAART. We did a randomised trial of structured treatment interruption in Abidjan, Côte d'Ivoire.


METHODS
HIV-infected adults were randomised to receive continuous HAART (CT), CD4-guided HAART (CD4GT) with interruption and reintroduction thresholds at 350 and 250 cells per mm3, respectively, or 2-months-off, 4-months-on HAART. Primary endpoints were death and severe morbidity (any WHO stage 3 or 4 events and any events leading to death) at month 24. We report data from the CT and CD4GT groups until Oct 31, 2005, when the data safety monitoring board recommended to prematurely stop the CD4GT arm. Analyses were intention-to-treat. This study is registered at ClinicalTrials.gov, number NCT00158405.


RESULTS
326 adults (median CD4 count nadir 272 per mm3) were randomised to the CT or CD4GT groups and followed up for median of 20 months. Incidence of mortality (per 100 person-years) was not different between groups (CT 0.6, CD4GT 1.2; p=0.57). Incidence of severe morbidity (per 100 person-years) was higher in the CDG4T group (17.6) than in the CT group (6.7; p=0.001). The most frequent severe events were invasive bacterial diseases. 79% of severe morbidity episodes occurred in patients with CD4 count 200-500 per mm3.


CONCLUSIONS
Patients on CD4GT had severe morbidity rates 2.5-fold higher than those on CT. This difference was mainly due to high rates of common diseases in patients with CD4 count 200-500 per mm3. This CD4-guided structured treatment interruption strategy should not be recommended in Abidjan.
Danel
Christine
C
Programme PAC-CI, Abidjan, Côte d'Ivoire.
Moh
Raoul
R
Minga
Albert
A
Anzian
Amani
A
Ba-Gomis
Olivier
O
Kanga
Constance
C
Nzunetu
Gustave
G
Gabillard
Delphine
D
Rouet
François
F
Sorho
Souleymane
S
Chaix
Marie-Laure
ML
Eholié
Serge
S
Menan
Hervé
H
Sauvageot
Delphine
D
Bissagnene
Emmanuel
E
Salamon
Roger
R
Anglaret
Xavier
X
D000328:Adult; D023241:Antiretroviral Therapy, Highly Active / Q000379:methods*; D018791:CD4 Lymphocyte Count; D007560:Cote d'Ivoire / Q000453:epidemiology; D004334:Drug Administration Schedule; D005260:Female; D015658:HIV Infections / Q000145:classification / Q000188:drug therapy* / Q000453:epidemiology; D006801:Humans; D015994:Incidence; D008297:Male; D012720:Severity of Illness Index; D019562:Viral Load