AMC-068 is a randomized phase II  multi-center clinical trial which compares of intravenous versus oral chemotherapy for HIV-positive individuals with diffuse large B-cell lymphoma. A total of 90 participants are expected to be enrolled with 45 particpants enrolled in each arm.

The purpose of this study is to see if a mixture of anti-cancer medicines given by mouth is as good as a mixture of anti-cancer medicines given by vein for treating Africans with AIDS and NHL. This study will help develop better treatments for people with AIDS and cancer in Africa.

AIDS-Related Non-Hodgkin’s Lymphoma (AR-NHL)

Approximately 10% of the world population lives in sub-Saharan Africa, but the region is home to approximately 68% of the world population living with HIV1. Most countries in this region have an HIV prevalence of at least 10% with a number of countries having a prevalence that exceeds 20%2. As the AIDS pandemic advances, the burden of related neoplastic disease is increasing in developing nations3,4. While under-developed cancer registries in sub-Saharan Africa bar a definitive statement being made regarding increases in incidence and prevalence in Africa, it is felt that AIDS-Related Non-Hodgkin’s Lymphoma

(AR-NHL) has rising incidence in this setting. Investigators involved in this study have previously published data that outcomes of AR-NHL are worse than NHL in seronegative patients5. Unfortunately, building on this observation is difficult, as there have been few published data on the tolerance and outcomes of treatment for HIV-associated non-Hodgkin lymphoma (NHL) in sub-Saharan Africa or on the most effective treatment regimen(s) in the varied clinical settings that exist within the region. Although all of the AMC African trial

sites cite CHOP as a “standard of care” for initial treatment of HIV-associated NHL, only one, the Uganda Cancer institute (UCI), has published information on treatment outcomes.

The most comprehensive accounting of newly diagnosed NHL, from the UCI and recently published by Bateganya et al6, remains limited; between 2004 and 2008 only 51 HIV-infected patients were identified. Although CHOP chemotherapy was administered to approximately two-thirds of all patients, the estimated median survival, even among HIV-seronegative individuals, was less than 1 year and the authors found no evidence that receipt of chemotherapy improved survival. HIV-positive patients receiving antiretroviral therapy had survival rates approximating those of HIV-negative persons, but the adjusted hazard of death was significantly elevated among HIV-positive patients not receiving antiretroviral therapy [adjusted hazard ratio (HR) 8.99, P < 0.001] compared with HIV-negative patients. An updated and as yet unpublished analysis (P. Imani and C. Casper, Personal Communication, January 2012) showed that of the 37 HIV+ patients in this study who received CHOP

chemotherapy, 34 received at least 70% of the standard dose. However, only 4 of 34 patients received at least 6 cycles of chemotherapy. The estimated median survival for all HIV+ patients who received CHOP was approximately 6 months, and only one patient was known

to be alive at 2 years. Interpreting the reason for the poor outcome for both HIV-infected and HIV-uninfected individuals is complicated by a high loss to follow-up rate and lack of information on therapy-related complications and causes of death7, not to mention issues

related to the purity and potency of locally-sourced chemotherapeutic agents.