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ANRS 1295/12160 - CIPRA KH001/10425 trial. The CAMELIA trial CAM bodian E arly vs. L ate I ntroduction of A ntiretrovirals. F.X. Blanc , T. Sok, D. Laureillard, L. Borand, C. Rekacewicz, E. Nerrienet, Y.Madec, O. Marcy, S. Chan, N. Prak, C. Kim, K.K. Lak, C. Hak, B. Dim,

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the camelia trial cam bodian e arly vs l ate i ntroduction of a ntiretrovirals

ANRS 1295/12160 - CIPRA KH001/10425 trial

The CAMELIA trialCAMbodianEarly vs. Late Introduction of Antiretrovirals

F.X. Blanc, T. Sok, D. Laureillard, L. Borand, C. Rekacewicz, E. Nerrienet,

Y.Madec, O. Marcy, S. Chan, N. Prak, C. Kim, K.K. Lak, C. Hak, B. Dim,

C.I. Sin, S. Sun, B. Guillard, B. Sar, S. Vong, M. Fernandez, L. Fox,

J.F. Delfraissy, A.E. Goldfeld.

22nd July 2010

LateBreaker Session B-1, XVIII IAS Conference, Vienna, Austria

slide2

HAART in TB-HIV: Early or late?

Adapted from J Acquir Immune Defic Syndr 2007; 46: S9-S18.

slide3

WHO recommendations

2003: CD4 < 200/mm3:

- Start TB treatment.

- Start ART as soon as TB treatmentistolerated (between 2 weeks and 2 months)

- Efavirenz-containingregimens

2010: - Start ART in all HIV-infectedindividualswith active TB, irrespectiveof the CD4 cell count. Strongrecommendation, lowquality of evidence.

- Start TB treatment first, followed by ART as soon as possible afterwards (and within the first eightweeks). Strongrecommendation, moderatequality of evidence.

- Use efavirenz as the preferred NNRTI in patients starting ART while on TB treatment. Strongrecommendation, highquality of evidence.

slide4

CAMELIA study design (2003-2004)

  • Prospective, randomized, open-label, two-armed trial with no placebo
  • Designed as a superiority trialto answer the question of the best timing for the introduction of HAART in severely immunosuppressed (CD4 ≤ 200/mm3) HIV-infected adult patients with newly diagnosed TB in Cambodia
  • 2 arms: late introduction of ART (reference arm: 8 weeks) vs.early(2 weeks) introduction of the same HAART
  • Primaryendpoint: survivalat the end of the trial (intent-to-treatanalysis)

ANRS 1295/12160 - CIPRA KH001/10425 study

slide5

CAMELIA strategy

Switch D4T to AZT

ANRS 1295/12160 - CIPRA KH001/10425 study

slide6

CAMELIA key points

  • - 2 sponsors: French ANRS and U.S. NIH/DAIDS (CIPRA)
  • Partnership with Cambodian Health Committee
  • 5 study sites (rural and urban) in Cambodia
  • 661 patients were AFB+ at inclusion (pulmonary or extra-pulmonary TB) with CD4 ≤ 200/mm3
  • 1st patient enrolled on January 31st 2006
  • 6 DSMB meetings
  • Last patient enrolled on May 27th 2009
  • End of the study: May 2010

ANRS 1295/12160 - CIPRA KH001/10425 study

slide7

CAMELIA recruitment

778 patients screened

117 patients not enrolled due to:

- CD4>200 (n=78)

- LFT impairment (n=24)

- pregnancy (n=3)

- TB treatment >1month (n=2)

- CD4 >200 & LFT impairment (n=2)

- death before randomization (n=2)

- pregnancy & LFT impairment (n=1)

- no CD4 at enrolment (n=1)

- high bilirubine (n=1)

- delay in blood sampling (n=1)

- CD4>200 & pregnancy (n=1)

- ART history & LFT impairment (n=1)

661 patients randomized

332 randomized to

the EARLY arm

329 randomized to the LATE arm

282

culture + M.tb

38

culture -

12

NTM

294

culture + M.tb

31

culture -

4

NTM

M.Tb: Mycobacterium tuberculosis; NTM: nontuberculous mycobacteria

ANRS 1295/12160 - CIPRA KH001/10425 study

slide8

Patient characteristics at enrollment

ANRS 1295/12160 - CIPRA KH001/10425 study

slide9

Characteristics of tuberculosis

ANRS 1295/12160 - CIPRA KH001/10425 study

slide10

SIGNIFICANT REDUCTION OF MORTALITY

IN THE EARLY ARM

* expressed in person-years

** per 100 person-years

12 patients (1.8%) lost to follow-up.

8,955 protocol visits, <2% missed visits.

ANRS 1295/12160 - CIPRA KH001/10425 study

slide11

Kaplan-Meier survival curves

Log-rank p-value: p=0.0042

ANRS 1295/12160 - CIPRA KH001/10425 study

slide12

Factors independently associated with mortality

Cox proportional hazard model

ANRS 1295/12160 - CIPRA KH001/10425 study

* Also adjusted for site and CD4 level at baseline (stratification factors)

slide13

IRIS significantly more frequent in the early arm

* expressed in person-months

** per 100 person-months

Time after TB treatment initiation (weeks)

ANRS 1295/12160 - CIPRA KH001/10425 study

slide14

>95% undetectable viral loadatweek 50

Plasma viral load (VL) measured by real time PCR for HIV-1 RNA plasmatic quantification (ANRS kit).

ANRS 1295/12160 - CIPRA KH001/10425 study

slide15

CD4 increase from baseline

Week 0: median CD4+ cell count was 25/mm3

Median CD4 increase at week 50: 114/mm3

ANRS 1295/12160 - CIPRA KH001/10425 study

slide16

CONCLUSIONS

1.Mortalitywasreduced by 34% when HAART wasinitiated 2 weeksvs. 8 weeksafteronset of TB treatment.

2. Irrespective of study arm, HAART has been extremelysuccessful, as evidenced by >95% of patients withundetectable viral load.

3.Despiteextremelylow CD4+ cell count at inclusion, patients enrolled in thispivotalstrategic trial have been extremelyadherent.

4. HAART initiation 2 weeksafteronset of TB treatmentcouldpotentiallysave 150,000 of the 450,000 annual HIV-TB deaths.

ANRS 1295/12160 - CIPRA KH001/10425 study

slide17

ACKNOWLEDGEMENTS

Sponsors: ANRS and NIH/DAIDS

Cambodian Health Committee

Institut Pasteur du Cambodge

Médecins Sans Frontières – Belgium

Cambodian Ministry of Health

Cambodian National TB Program (CENAT)

Cambodian National AIDS Program (NCHADS)

Study sites: Khmer-Soviet Friendship Hospital (Phnom Penh), Donkeo Provincial Hospital (Takeo), Calmette Hospital (Phnom Penh), Svay Rieng Provincial Hospital and Siem Reap Referral Hospital

Investigators, nurses, technicians, monitors, social workers…

Members of the DSMB and the Scientific Advisory Board

And especially all the patients and PLWHA representatives who joined us in this challenge.

ANRS 1295/12160 - CIPRA KH001/10425 study