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

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.

Conditions

• HIV
• AIDS
• Kaposi's Sarcoma
• Human Herpesvirus 8

Interventions

DRUG

Generic HAART Triomune : d4T, 3TC, NVP

Triomune® (Cipla, Mumbai) Stavudine 40mg b.d \> 60 kg , 30mg bd \<60kg Lamivudine 150mg b.d \> 50 kg 2mg/kg \< 50 kg Nevirapine 200mg b.d ( 200mg daily for first 2 weeks)

DRUG

Generic HAART Triomune : d4T, 3TC, NVP and chemotherapy ABV

Triomune® (Cipla, Mumbai) Stavudine 40mg b.d \> 60 kg , 30mg bd \<60kg Lamivudine 150mg b.d \> 50 kg 2mg/kg \< 50 kg Nevirapine 200mg b.d ( 200mg daily for first 2 weeks) Intramuscular Bleomycin 10 U/m2 ; Intravenous Vincristine 1.4mg/m2 maximum 2mg and Intravenous Doxorubicin 20mg/m2.

Sponsors & Collaborators

• AIDS Care Research in Africa

  collaborator OTHER

• National Research Foundation, Singapore

  collaborator OTHER_GOV

• AIDS Malignancy Consortium

  collaborator NETWORK

• Cipla Medpro

  collaborator INDUSTRY

• Dermatological Society of South Africa

  collaborator UNKNOWN

• University of KwaZulu

  lead OTHER

Principal Investigators

• Anisa Mosam, FC Derm,PhD · Nelson R Mandela School of Medicine, University of Kwazulu Natal

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2003-01-31

Primary Completion

2009-02-28

Completion

2009-03-31

Countries

• South Africa

Study Locations