HIV/AIDS Kaposis Sarcoma: Comparison of Response to HAART vs HAART Plus CXT (KAART)
HIV, AIDS, Kaposi's Sarcoma
About this trial
This is an interventional treatment trial for HIV focused on measuring HIV, AIDS, Kaposi's sarcoma, Human herpesvirus 8
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
• 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.
Sites / Locations
- Department of Dermatology, King Edward VIII Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
HAART alone
Combination HAART and chemotherapy
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)
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.