Randomized Phase IIA Trial of Gemcitabine Compared With Bleomycin Plus Vincristine for Treatment of Kaposi's Sarcoma in Patients on Combination Antiretroviral Therapy in Western Kenya.

PURPOSE: Kaposi's sarcoma (KS) is a spindle cell tumor resulting from growth dysregulation in the setting of infection with human herpes virus-8 (also called KS herpes virus). Advanced KS is characterized by poor responses to antiretroviral therapy and some of the chemotherapy readily accessible to patients in low-resource areas. Gemcitabine induced partial and complete regression of AIDS-associated KS (AIDS-KS) in 11 of 24 patients in a pilot study. The current study compares the antimetabolite gemcitabine with the standard care bleomycin and vincristine (BV) in the treatment of chemotherapy-naïve patients with AIDS-KS in a resource-limited setting. PATIENTS AND METHODS: Patients with persistent or progressive KS despite treatment with combined antiretroviral therapy were randomly assigned to receive gemcitabine 1,000 mg/m2 or bleomycin 15 IU/ m2 and vincristine 1.4 mg/m2 given twice weekly. The main end point was objective response by bidirectional measurement, adverse events, and quality of life after three cycles of chemotherapy. RESULTS: Of 70 participants enrolled, 36 received gemcitabine and 34 received BV. Complete response was achieved in 12 patients (33.3%) in the gemcitabine arm and six (17.6%) in the BV arm ( P = .175). The partial response rate was 52.8% (n = 19) in the gemcitabine arm and 58.8% (n = 20) in the BV arm. Both study arms reported similar neurologic and hematologic adverse events; there was statistically significant baseline to post-treatment improvement in health-related quality-of-life scores. CONCLUSION: The results of this randomized, phase IIA trial demonstrate gemcitabine activity in chemotherapy-naïve patients with AIDS-KS, on the basis of response rates, adverse events, and health-related quality-of-life scores.

Medicinal plants used by traditional medicine practitioners for the treatment of HIV/AIDS and related conditions in Uganda.

INTRODUCTION AND OBJECTIVES: In Uganda, there are over one million people with HIV/AIDS. When advanced, this disease is characterized by life-threatening opportunistic infections. As the formal health sector struggles to confront this epidemic, new medicines from traditional sources are needed to complement control efforts. This study was conducted to document herbal medicines used in the treatment of HIV/AIDS and related opportunistic infections, and to document the existing knowledge, attitudes and practices related to HIV/AIDS recognition, control and treatment in Sembabule, Kamuli, Kabale and Gulu districts in Uganda. METHODS: In this study, 25 traditional medicine practitioners (TMPs) were interviewed using structured questionnaires. RESULTS: The TMPs could recognize important signs and symptoms of HIV/AIDS and its associated opportunistic infections. The majority of practitioners treated patients who were already receiving allopathic medicines including antiretroviral drugs (ARVs) prescribed by allopathic practitioners. There were 103 species of medicinal plants identified in this survey. Priority plants identified include Aloe spp., Erythrina abyssinica, Sarcocephalus latifolius, Psorospermum febrifugum, Mangifera indica and Warburgia salutaris. There was low consensus among TMPs on the plants used. Decoctions of multiple plant species were commonly used except in Gulu where mono-preparations were common. Plant parts frequently used were leaves (33%), stem bark (23%) and root bark (18%). About 80% of preparations were administered orally in variable doses over varied time periods. The TMP had insufficient knowledge about packaging and preservation techniques. CONCLUSIONS: Numerous medicinal plants for treatment of HIV/AIDS patients were identified in the four districts surveyed and the role of these plants in the management of opportunistic infections warrants further investigation as these plants may have a role in Uganda's public health approach to HIV/AIDS control.

Medicinal plants used by traditional medicine practitioners in the treatment of tuberculosis and related ailments in Uganda.

AIM OF THE STUDY: Tuberculosis (TB) remains one of the most difficult ailments to control in the world today. The emergence of drug resistant strains has made previously effective and affordable remedies less effective. This has made the search for new medicines from local traditional medicines urgent. The specific objectives of this study were to (1) identify plant species used in the treatment of TB, their methods of preparation and administration, (2) document TB recognition, and (3) document medicine processing and packaging practices by traditional medicine practitioners (TMPs). METHODS: We interviewed 32 TMPs from the districts of Kamuli, Kisoro and Nakapiripirit using a guided questionnaire. RESULTS: We documented 88 plant species used to treat TB. Seven of these, Eucalyptus spp., Warburgia salutaris (G. Bertol.) Chiov., Ocimum suave Willd., Zanthoxylum chalybeum Engl., Momordica foetida Schum., Persea americana Mill. and Acacia hockii De Wild. were mentioned by three or more TMPs. Medicines were prepared mostly as mixtures or infrequently as mono-preparations in dosage forms of decoctions and infusions. They were administered orally in variable doses over varying periods of time. The TMPs did not know how to preserve the medicines and packaged them in used water bottles. Almost all TMPs mentioned the most important signs by which TB is recognised. They also knew that TB was a contagious disease spread through poor hygiene and crowding. CONCLUSIONS: Local knowledge and practices of treating TB exist in the districts surveyed. This knowledge may be imperfect and TMPs appear to be still experimenting with which species to use to treat TB. There is need to screen among the species mentioned to determine those which are efficacious and safe. The technology of processing, packaging and preserving traditional medicines for the treatment of TB is very basic and needs improving. The TMPs appear to be playing a significant role in primary health care delivery and this lends further justification for the ongoing Uganda government efforts to integrate the allopathic and traditional medicine systems.

Existing capacity to manage pharmaceuticals and related commodities in East Africa: an assessment with specific reference to antiretroviral therapy.

BACKGROUND: East African countries have in the recent past experienced a tremendous increase in the volume of antiretroviral drugs. Capacity to manage these medicines in the region remains limited. Makerere University, with technical assistance from the USAID supported Rational Pharmaceutical Management Plus (RPM Plus) Program of Management Sciences for Health (MSH) established a network of academic institutions to build capacity for pharmaceutical management in the East African region. The initiative includes institutions from Uganda, Tanzania, Kenya and Rwanda and aims to improve access to safe, effective and quality-assured medicines for the treatment of HIV/AIDS, TB and Malaria through spearheading in-country capacity. The initiative conducted a regional assessment to determine the existing capacity for the management of antiretroviral drugs and related commodities. METHODS: Heads and implementing workers of fifty HIV/AIDS programs and institutions accredited to offer antiretroviral services in Uganda, Kenya, Tanzania and Rwanda were key informants in face-to-face interviews guided by structured questionnaires. The assessment explored categories of health workers involved in the management of ARVs, their knowledge and practices in selection, quantification, distribution and use of ARVs, nature of existing training programs, training preferences and resources for capacity building. RESULTS: Inadequate human resource capacity including, inability to select, quantify and distribute ARVs and related commodities, and irrational prescribing and dispensing were some of the problems identified. A competence gap existed in all the four countries with a variety of healthcare professionals involved in the supply and distribution of ARVs. Training opportunities and resources for capacity development were limited particularly for workers in remote facilities. On-the-job training and short courses were the preferred modes of training. CONCLUSION: There is inadequate capacity for managing medicines and related commodities in East Africa. There is an urgent need for training in aspects of pharmaceutical management to different categories of health workers. Skills building activities that do not take healthcare workers from their places of work are preferred.