Interferon-α2b with protease inhibitor-based antiretroviral therapy in patients with AIDS-associated Kaposi sarcoma: An AIDS malignancy consortium phase I trial Journal Article
| Authors: | Krown, S. E.; Lee, J. Y.; Lin, L.; Fischl, M. A.; Ambinder, R.; Von Roenn, J. H. |
| Article Title: | Interferon-α2b with protease inhibitor-based antiretroviral therapy in patients with AIDS-associated Kaposi sarcoma: An AIDS malignancy consortium phase I trial |
| Abstract: | We evaluated the safety and maximum tolerated dose of interferon (IFN)-α2b in combination with protease inhibitor-based highly active antiretroviral therapy (HAART) in a phase 1 study in 14 patients with AIDS-associated Kaposi sarcoma (KS). Planned IFN dose levels were 0, 1, 5, 10, and 15 million IU administered by daily subcutaneous injection. Dose-limiting toxicities were neutropenia and malaise. The maximum tolerated IFN dose was 5 million IU/d. The median CD4 count increased from 260 cells/μL at baseline to a maximum on-study value of 359 cells/μL. In 6 patients with paired baseline and on-study values, the median HIV RNA level decreased from 20,179 copies/mL to a minimum on-study value of 309 copies/mL. Of 13 patients whose KS response could be evaluated, 5 showed objective tumor regression. Responses occurred in HAART-experienced and HAART-naive subjects. Five patients, including 2 responders, 2 with stable KS, and 1 with progression, had serial measurements of Kaposi sarcoma herpesvirus (KSHV) load. None of these patients, irrespective of treatment arm or KS response, showed durable clearance of KSHV from plasma or peripheral blood mononuclear cells. This study establishes a safe dose of IFN that can be used with HAART and, potentially, with other inhibitors of KS in future clinical trials. Copyright © 2006 by Lippincott Williams & Wilkins. |
| Keywords: | adult; clinical article; treatment outcome; aged; middle aged; clinical trial; fatigue; neutropenia; diarrhea; drug safety; treatment duration; liver dysfunction; polymerase chain reaction; alpha2b interferon; infection; anemia; leukopenia; nausea; thrombocytopenia; drug administration schedule; herpes zoster; food and drug administration; tumor regression; virology; fever; lymphedema; bilirubin; malaise; virus rna; remission; remission induction; antivirus agent; human immunodeficiency virus; acquired immune deficiency syndrome; cd4 lymphocyte count; highly active antiretroviral therapy; kaposi sarcoma; virus load; antiretroviral therapy, highly active; sarcoma, kaposi; maximum tolerated dose; phase 1 clinical trial; aminotransferase; drug administration; injections, subcutaneous; proteinase inhibitor; peripheral blood mononuclear cell; human herpesvirus 8; herpesvirus 8, human; lamivudine; antiviral agents; interferon-α; recombinant alpha2b interferon; indinavir; viral load; stavudine; aids-related opportunistic infections; rna directed dna polymerase inhibitor; ritonavir; nelfinavir; interferon alfa-2b; aids related complex; didanosine; abacavir; amprenavir; subcutaneous drug administration; kaposi sarcoma herpesvirus; hiv protease inhibitors |
| Journal Title: | JAIDS: Journal of Acquired Immune Deficiency Syndromes |
| Volume: | 41 |
| Issue: | 2 |
| ISSN: | 1525-4135 |
| Publisher: | Lippincott Williams & Wilkins |
| Date Published: | 2006-02-01 |
| Start Page: | 149 |
| End Page: | 153 |
| Language: | English |
| DOI: | 10.1097/01.qai.0000194237.15831.23 |
| PUBMED: | 16394845 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | --- - "Cited By (since 1996): 18" - "Export Date: 4 June 2012" - "CODEN: JJASF" - "Source: Scopus" |
