Status:
COMPLETED
HIV/AIDS Kaposis Sarcoma: Comparison of Response to HAART vs HAART Plus CXT
Lead Sponsor:
University of KwaZulu
Collaborating Sponsors:
AIDS Care Research in Africa
National Research Foundation, Singapore
Conditions:
HIV
AIDS
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ar...
Detailed Description
DETAILED METHODOLOGY PRIMARY OBJECTIVES: 1.To compare the clinical response of HIV KS at month 12 in patients treated with HAART alone with those treated with the combination of HAART and chemothera...
Eligibility Criteria
Inclusion
- Signed informed consent
- Adults \> 18 years
- Documented HIV positive status (Confirmed by two ELISAs and HIV-1 RNA testing)
- Willingness to use a barrier method of birth control throughout the course of the study, because of potential drug interactions that make oral contraceptives less effective (for women of childbearing potential) and sexually active males
- Histologically proven
- At least five measurable, previously unirradiated cutaneous lesions must be present which can be used as indicator lesions.
- ECOG performance status 0-2
Exclusion
- • Pregnancy or breastfeeding
- Fungating tumors of KS
- Symptomatic pulmonary KS
- Symptomatic GI tract KS
- Clinical evidence of peripheral neuropathy
- Clinical evidence of heart disease
- Total neutrophil count of \< 1,000u/L, Hemoglobin \< 9.0gm/dl or platelet count of \< 75,000u/L; serum creatinine \> 1.5mgh/dl, direct serum bilirubin \> 85 umol/l, AST or ALT \> 2.5 time ULN.
- Prior HAART ( to fairly evaluate antiretroviral response and KS response to HAART, patients should be antiretroviral naïve)
- Prior radiation therapy for KS to sites of indicator lesions.
- Prior cytotoxic chemotherapy for KS.
- Concurrent neoplasia requiring cytotoxic therapy.
- Life expectancy of \< 3 months.
- Circumstances, which in the opinion of the investigator make it unlikely the patient, can comply with the safety monitoring required for participation in this trial.
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT00380770
Start Date
January 1 2003
End Date
March 1 2009
Last Update
July 21 2010
Active Locations (1)
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1
Department of Dermatology, King Edward VIII Hospital
Durban, KwaZulu-Natal, South Africa, 4001