HIV/AIDS Kaposis Sarcoma: Comparison of Response to HAART vs HAART Plus CXT
Status:
Completed
Trial end date:
2009-03-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
University of KwaZulu
Collaborators:
AIDS Care Research in Africa AIDS Malignancy Consortium Cipla Medpro Dermatological Society of South Africa National Research Foundation, Singapore
Treatments:
Lamivudine Nevirapine Stavudine Stavudine, lamivudine, nevirapine drug combination