drugset / Trial / NCT00380770

HIV/AIDS Kaposis Sarcoma: Comparison of Response to HAART vs HAART Plus CXT

NCT00380770

RandomizedParallel-groupOpen-labelTreatment

Summary

Kaposi's sarcoma (KS)is the commonest malignancy associated with HIV/AIDS. Therapy for this cancer, which causes substantial morbidity, is suboptimal in resource poor settings. The reasons for this are: advanced state of immunosuppression when patients present for clinical care, concomitant opportunistic infections, non- availability of antiretroviral therapy (ART), non-availability and toxicity of chemotherapy (CXT), when available, in patients with full blown AIDS, prohibitive costs of bone marrow support and fiscal constraints in resource poor settings. A recent Cochrane Review assessed the effectiveness of current therapeutic regimens for HIV KS, with a focus on options available in resource poor settings. The major selection criteria for this review were randomized controlled trials for HIV KS in adults. The main conclusions were that data from randomized controlled trials on effective treatments for HIV KS are sparse, particularly among people who are also taking highly active antiretroviral therapy (HAART). Alitretinoin gel is effective for therapy of cutaneous lesions, pegylated liposomal doxorubicin is effective for advanced KS and radiotherapy is effective for treating cutaneous lesions. Apart from the randomized trial of radiotherapy, no trials applicable to developing settings were identified. Therapy of HIV KS in developing countries thus remains unanswered. The authors concluded that therapies discussed in the review are unlikely to be available or affordable in developing countries where the bulk of HIV infection and KS occur, apart from radiotherapy at a few tertiary centers. However, recent changes in pricing due to the global alliance and access initiatives mean that HAART is likely to be more available and accessible to developing countries in the near future. South Africa now has committed to this at cabinet level and had a task force to address this issue. HAART has been proposed as therapy for HIV KS on the basis of restoring immune competence and minimizing the HIV tat drive to KS formation. It also improves immunologic control of HHV 8 possibly through interrupting the HIV-1- HHV-8 interaction. There has been only one randomised trial conducted in Spain which compared HAART to the combination of HAART and CXT. There is to date no prospective, randomised controlled trial which compares the efficacy of HAART to the standard of care in HIV KS in Africa.

Timeline

Start
2003-01
Primary completion
2009-02
Completion
2009-03

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bleomycin Unknown 10 unknown Intramuscular
Comparator Doxorubicin Other / unclassified 20 mg/m2 Intravenous
Subject Lamivudine Other / unclassified 2 mg/kg Oral
Subject Lamivudine Other / unclassified 150 mg Oral
Subject Nevirapine Small molecule 200 mg Oral
Subject Stavudine Other / unclassified 30 mg Oral
Subject Stavudine Other / unclassified 40 mg Oral
Comparator Vincristine Small molecule 1.4 mg/m2 Intravenous