5 Monivong Boulevard, P.O Box. 983, Phnom Penh, Cambodia [email protected]

The CAMELIA ANRS 1295 / CIPRA KH001 trial showed that initiating ART 2 weeks after the start of tuberculosis treatment significantly improved survival among HIV-infected adults with CD4+ T-cell counts of 200 per cubic millimeter or lower.

(N Engl J Med. 2011 Oct 20; 365(16):1471-81)

The CAMELIA (for CAMbodian Early vs. Late Introduction of Antiretroviral therapy, ANRS 1295/12160-CIPRA KH001/10425) study was a randomized, open-label, superiority clinical trial with no placebo with two study arms. It was designed to determine whether early initiation of ART 2 weeks after the onset of tuberculosis treatment, as compared to 8 weeks, could increase survival in patients with newly diagnosed tuberculosis and advanced immunodeficiency. The trial was conducted in 5 Cambodian hospitals from January 31, 2006 to May 27, 2010. The results for the primary objective have been published (N Engl J Med. 2011 Oct 20; 365(16):1471-81). A recent article was accepted in Antiviral Therapy concerning the issue of the efavirenz dosage in patients weighing above 50 kg and receiving rifampicin based TB-therapy concomitantly. Other articles are under preparation.

[email protected] team leaders

Laurence Borand, Pheng Phearavin, Manil Saman, Arnaud Tarantola

Financial support

The CAMELIA clinical trial was sponsored by the ANRS (ANRS 12 95) and the NIH (CIPRA KH 001).

Ongoing studies

Standard-dose of EFV in Cambodians adults infected with TB/HIV with a body weight ≥ 50 kg.

Borand L, Laureillard D, Madec Y, Chou M, Pheng P, Marcy O, Sok T, Goldfeld A, Taburet AM and Blanc FX for the CAMELIA (ANRS 1295-CIPRA KH001) study team. Plasma concentrations of efavirenz with a 600 mg standard-dose in Cambodian HIV-infected adults treated for tuberculosis with a body weight above 50 kg. Antiviral Therapy. Accepted for publication.

Offshoots of the CAMELIA ANRS 1295 / CIPRA KH001 trial are showing that daily doses of 600 mg EFV constitute a safe and effective treatment, irrespective of body weight or importance of viral load.

Borand L, Laureillard D, Madec Y, Chou M, Pheng P, Marcy O, Sok T, Goldfeld A, Taburet AM and Blanc FX for the CAMELIA (ANRS 1295-CIPRA KH001) study team. Plasma concentrations of efavirenz with a 600 mg standard-dose in Cambodian HIV-infected adults treated for tuberculosis with a body weight above 50 kg. Abstract submitted to the 43rd Union World Conference on Lung Health-Kuala Lumpur.

Background: The optimal dose of efavirenz for HIV-infected patients receiving a tuberculosis regimen including rifampicin remains debated, especially for subjects weighing over 50 kg. To address this issue, we measured plasma efavirenz concentrations from Cambodian adults with tuberculosis enrolled in the CAMELIA randomized trial (ClinicalTrials.gov number, NCT01300481) six weeks after the onset of antiretroviral therapy.

Methods: Efavirenz concentrations and proportions of patients with concentrations below 1000 ng/mL were compared across patient body weight below or above 50 kg using a Student’s t-test and a chi-squared test, respectively. Factors associated with efavirenz concentrations below 1000 ng/mL were identified by logistic regression analysis. Logistic regression analysis was also performed to check if efavirenz concentrations below 1000 ng/mL were associated with virological failure.

Conclusion: The current WHO guidelines recommending 600 mg efavirenz daily irrespective of patient’s body weight remains a safe and effective approach to treating co-infected adults needing simultaneous tuberculosis and HIV therapy.

EFV and high viral loads in HIV/TB coinfected patients of the CAMELIA trial

Marcy O. Effect of pre-treatment HIV1 viral load on the efficacy of efavirenz-based first line antiretroviral therapy in patients treated for tuberculosis.  Submitted in part fulfillment of the requirements for the degree of Master in Public Health 2012.

Despite numerous clinical trials and observational studies assessing efficacy of EFV, data is scarce in patients with very high pre-ART HIV RNA. The aim of this post-hoc analysis of the CAMELIA study was to study the effect of a very high pre-ART HIV RNA on the proportion of virological success with EFV-based antiretroviral therapy at one year in HIV-infected patients initially treated for tuberculosis. We found that there was no significant association between a pre-ART HIV RNA level and the efficacy of an EFV-based ART in severely immunocompromised HIV-infected patients treated for tuberculosis. The probability of virological success at approximately one year of treatment was identical in patients with low and intermediate pre-ART HIV RNA (

EFV and medically-non-recommended pregnancies

P. Hancart Petitet, L. Borand, P. Pheng, S. Hong, O. Marcy, A. Hardon, A. Tarantola. Medically Non Recommended Pregnancies & clinical trials: Insights from the CAMELIA ANRS 1295-CIPRA KH001 in Cambodia. Presented at AIDS 2012 – Washington, D.C., USA, 22-27 July, 2012. Abstract N°MOPE420.

Epidemiological analysis of data contributed through CALIBAN will inform national antibiotic treatment guidelines for community-acquired pneumonia. The networking method will also be used for other subjects.

Despite various precautions and the requirement stated in the informed consent form, 19 (8%) of the 236 enrolled women became pregnant during the CAMELIA trial. We conducted a descriptive analysis of the women’s socio-demographic and biomedical characteristics, comparing baseline means and percentages in the women who became pregnant to that of those who did not. This multidisciplinary research brings various relevant insights from complementary, qualitative and quantitative approaches. It provides insights: 1/ On the socio-demographic and biomedical characteristics of the women who became pregnant and on the pregnancy occurrence and outcomes in the context of a clinical trial conducted in Cambodia: special focus may be given to women who are younger and married; especially once they recover from their tuberculosis. 2/ On the prevention and management of contraindicated pregnancies in any clinical trial (revise informed consent process with important messages reinforcement during follow-up; improve medical team training on reproductive health ; increase data collection related to social background for patients ; when possible involve patient’s partner in the process ; implement counseling session about procreative issues, especially after 6 months when clinical status improves dramatically and after 12 months, time around which most pregnancies began). It also raises new theoretical insights for anthropology (Alliance & Kinship in contemporary Cambodia, matrimonial strategies and parenthood in precarious context, commodification of children, reproductive issues and HIV, social construction and social production of clinical trials).

To come: ANRS 12 278 on the link between the M. tuberculosis strain and severity of tuberculosis outcome.