Response to liposomal doxorubicin and clinical outcome of HIV-1-infected patients with Kaposi's sarcoma receiving highly active antiretroviral therapy

HIV Clin Trials. 2001 Sep-Oct;2(5):429-37. doi: 10.1310/700b-9qt3-hgn9-q3fq.


Purpose: HIV-associated Kaposi's sarcoma (KS) may not resolve despite highly active antiretroviral therapy (HAART). Moreover, the therapeutic goal has shifted from palliative care to long-term durable complete remission. The objective of the study was to assess the impact of liposomal doxorubicin in the treatment of HIV-associated KS in the HAART era.

Method: In this prospective, noncomparative, multicenter study, patients with more than 10 cutaneous lesions or visceral disease were treated with 20 mg/m(2) of liposomal doxorubicin (Caelyx) every 3 weeks in addition to their antiretroviral therapy. In addition to tumor measurements and laboratory tests, human herpes virus 8 (HHV-8) polymerase chain reaction (PCR) in peripheral blood mononuclear cells (PBMC) was performed.

Results: Out of 79 participants enrolled in the study, 47 (59%) had stage T(1), 41 (52%) I(1), and 32 (40%) S(1). Nine individuals were not evaluable for response, 32 (40%) had complete response, 30 (38%) partial response, 5 (6%) stable disease, and 3 (4%) progression. Regression analysis did not find any statistically significant factor predicting response. HHV-8 PCR was positive in 37/53 (70%) patients with available PBMC samples, and HHV-8 viremia cleared in 14/27 (52%) without correlation with clinical response. Eleven (14%) participants experienced a relapse of KS, while at the last update of data, 49 (62%) remained stable. The only risk factor for recurrence identified was the follow-up time (odds ratio [OR] 1.21, 95% CI 1.07-1.36; p =.002).

Conclusion: The response rate of AIDS-associated KS to liposomal doxorubicin administered with HAART was high, and most often the response was durable. HHV-8 viremia did not correlate well with clinical outcome.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase IV
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • AIDS-Related Opportunistic Infections / drug therapy*
  • Adult
  • Anti-HIV Agents / therapeutic use
  • Antineoplastic Agents / administration & dosage
  • Antineoplastic Agents / therapeutic use*
  • Antiretroviral Therapy, Highly Active
  • DNA, Viral / analysis
  • Doxorubicin / administration & dosage
  • Doxorubicin / adverse effects
  • Doxorubicin / therapeutic use*
  • Drug Therapy, Combination
  • Female
  • Gastrointestinal Diseases / chemically induced
  • HIV-1*
  • Hematologic Diseases / chemically induced
  • Herpesvirus 8, Human / genetics
  • Herpesvirus 8, Human / isolation & purification*
  • Humans
  • Leukocytes, Mononuclear / virology
  • Liposomes
  • Male
  • Prospective Studies
  • Sarcoma, Kaposi / drug therapy*
  • Sarcoma, Kaposi / virology
  • Treatment Outcome


  • Anti-HIV Agents
  • Antineoplastic Agents
  • DNA, Viral
  • Liposomes
  • Doxorubicin