A5263: Advanced KS Chemo

A Randomized Comparison of Three Regimens of Chemotherapy with Compatible Antiretroviral Therapy for Treatment of Advanced AIDS-KS in Resource-Limited Settings

Study Description

This study will compare three treatments for people who are infected with HIV and have advanced Kaposi’s sarcoma (a type of cancer linked to HIV infection) in resource-limited settings.  Participants will be randomly assigned (by chance) to receive either etoposide (ET), bleomycin-vincristine (BV), or liposomal doxorubicin (PLD).  These drugs will be given along with anti-HIV medications.

Why is this study being done?

To compare the efficacy of three treatment regimens for the first treatment of advanced stage AIDS-Kaposi’s sarcoma. 

Who can join?

  • HIV-infected men and women, 18 years or older
  • Have never taken medicine for HIV
  • Have advanced Kaposi’s sarcoma with skin lesions and never took medicine to treat it

What do I need to do in the study?

Participants will be randomized (assigned by chance) to one of the following treatment groups to take either: 

  • 1A: Etoposide for 7 days of every 3-week cycle (for maximum of 6 cycles)
  • 1B: Vincristine sulfate along with bleomycin sulfate over 30 minutes, every 3 weeks (for up to 6 cycles)
  • 1C: Liposomal doxorubicin every 3 weeks (for up to 6 cycles)

All participants in the three treatment groups will also take one Atripla® (efavirenz/tenofovir/FTC) tablet once a day.

All participants will remain on study for 5 years.

What treatments or drugs are involved with this study?

Etoposide is taken as capsules by mouth.  Vincristine, bleomycin, and liposomal doxorubicin (Doxil®) are given as liquids through a vein in the arm.

Study Status: