HIV/AIDS Kaposis Sarcoma: Comparison of Response to HAART vs HAART Plus CXT (KAART)
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|ClinicalTrials.gov Identifier: NCT00380770|
Recruitment Status : Completed
First Posted : September 26, 2006
Last Update Posted : July 21, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|HIV AIDS Kaposi's Sarcoma Human Herpesvirus 8||Drug: Generic HAART Triomune : d4T, 3TC, NVP Drug: Generic HAART Triomune : d4T, 3TC, NVP and chemotherapy ABV||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||112 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Randomized Trial Comparing the Response of HIV Kaposi's Sarcoma (KS) to HAART Versus the Combination of HAART and Chemotherapy (CXT)|
|Study Start Date :||January 2003|
|Actual Primary Completion Date :||February 2009|
|Actual Study Completion Date :||March 2009|
Experimental: HAART alone
Arm 1. HAART These patients will be given one tablet twice daily of 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
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)
Active Comparator: Combination HAART and chemotherapy
Arm 2. CTX PLUS HAART. HAART will be given as above. In addition, CTX will be administered at 2 weekly intervals in the Oncology Dept at KEH VIII Hospital and will consist of:- Intramuscular Bleomycin 10 U/m2 ; Intravenous Vincristine 1.4mg/m2 maximum 2mg and Intravenous Doxorubicin 20mg/m2.
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.
- Clinical response of KS [ Time Frame: 3 monthly ]Responses will be categorized as complete response(only with biopsy confirmation), complete clinical response, partial response, stable disease and disease progression according to ACTG criteria.
- Skin: tumour measurements of 5 indicator skin lesions. Assessment of KS as per AMC RKS 02 (www.amc.uab.edu) [ Time Frame: 3 monthly ]Measurement of the same 5 marker lesions (as per AMC RKS 02 )will be done at baseline, month 3, month 6, month 9 and month 12. Assessed by bi-directional diameter.
- photography of indicator lesions with metric tape in frame [ Time Frame: 6 monthly ]Clinical photographs taken of marker lesions (5 according to AMC criteria) will be taken at baseline, month 6 and 12.
- Visceral: chest radiograph and endoscopy, where necessary, bronchoscopy [ Time Frame: 6 monthly ]done in patients who presented with visceral KS at baseline to monitor the disease
- Safety and toxicity by DAIDS Toxicity criteria [ Time Frame: as they occur ]DAAIDS toxicity criteria used to assess and measure severity of adverse events
- Immunological and virological response to HAART as measured by CD4 and HIV-viral load [ Time Frame: 3 monthly ]patients CD4 and VL will be measured 3 monthly to assess immunological and virological control
- QOL by EORTC QLQ C30 [ Time Frame: 3 monthly ]EORTC QLQ C30 will be used as the tool to assess QOL in subjects
- Adherence [ Time Frame: monthly ]Adherence by 7 day adherence questionnaire Adherence will be measured using a standardized validated self administered questionnaire, which enables review of each medication during previous 7 days and a medication specific and overall adherence score.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00380770
|Department of Dermatology, King Edward VIII Hospital|
|Durban, Kwazulu Natal, South Africa, 4001|
|Principal Investigator:||Anisa Mosam, FC Derm,PhD||Nelson R Mandela School of Medicine, University of Kwazulu Natal|