Synergy, activity and tolerability of zidovudine and interferon-alpha in patients with symptomatic HIV-1 infection: ACTG 068 Journal Article
| Authors: | Mildvan, D.; Bassiakos, Y.; Zucker, M. L.; Hyslop, N. Jr; Krown, S. E.; Sacks, H. S.; Zachary, J.; Paredes, J.; Fessel, W. J.; Rhame, F.; Kramer, F.; Fischl, M. A.; Poiesz, B.; Wood, K.; Ruprecht, R. M.; Kim, J.; Grossberg, S. E.; Kasdan, P.; Bergé, P.; Marshak, A.; Pettinelli, C. |
| Article Title: | Synergy, activity and tolerability of zidovudine and interferon-alpha in patients with symptomatic HIV-1 infection: ACTG 068 |
| Abstract: | Thirty-four subjects with symptomatic HIV-1 infection, p24 antigenaemia, and CD4 cell counts > 200/mm3 were randomly assigned to receive treatment with either zidovudine (ZDV) orally, interferon-alpha (IFN-α) subcutaneously, or both at respective low (200 mg ZDV/2 million international units IFN-α (MIU)), middle (400 mg/4 MIU) or high (600 mg/6 MIU) daily dose levels for 12 weeks. Thereafter, all patients received combination therapy at the initially assigned dose level to a total of 96 weeks. This design permitted analysis by the combination index (CI) method, which demonstrated antiretroviral synergy between ZDV and IFN-α with respect to p24 antigen suppression. Over the first 12 weeks, combination therapy was acceptably tolerated, more so than IFN-α monotherapy, and it was significantly more active in suppressing antigenaemia than either of the monotherapies. Similarly, the high-dose combination was the most active dose level over weeks 12 to 96. Combination ZDV/IFN-α. at the optimal dose level defined by this trial merits further study. In addition, the CI design strategy employed here may be useful for the investigation of new antiretroviral combinations. © 1996 MediTech Media. |
| Keywords: | adult; controlled study; clinical trial; drug potentiation; alpha interferon; human immunodeficiency virus infection; controlled clinical trial; randomized controlled trial; drug synergism; blood; drug combination; drug therapy, combination; antivirus agent; cd4 lymphocyte count; administration, oral; drug tolerance; anti-hiv agents; hiv infections; human immunodeficiency virus 1; interferon-alpha; hiv-1; oral drug administration; zidovudine; antiviral agents; intradermal drug administration; administration, cutaneous; gag protein; anti human immunodeficiency virus agent; humans; human; male; female; article; hiv core protein p24 |
| Journal Title: | Antiviral Therapy |
| Volume: | 1 |
| Issue: | 2 |
| ISSN: | 1359-6535 |
| Publisher: | International Medical Press |
| Date Published: | 1996-04-01 |
| Start Page: | 77 |
| End Page: | 88 |
| Language: | English |
| PUBMED: | 11321183 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | Article -- Export Date: 22 November 2017 -- Source: Scopus |
