Sixteen-Week Analysis of Heavily Pre-Treated Patients Receiving T-20 As A Component of Multi-Drug Salvage Therapy (T20-205)

Presented at the 39th Interscience Conference on Antimicrobial Agents and Chemotherapy
San Francisco, CA, September 26-29, 1999

Study Objective: To evaluate the safety and antiviral activity of T-20, in combination with oral antiretroviral agents in heavily pre-treated HIV-infected patients.
Design: Phase II open-label roll-over protocol
  • T-20 (50 mg/twice daily via self-administered subcutaeous injection) in combination with oral antiretrovirals. Combinations were individualized to each patient and were chosen based on genotypic analysis.
Population: 55 HIV-1 positive adult patients who had enrolled in earlier clinical trials (TRI-001, TRI-002 or TRI-003)
  • Patients had previously been treated with a median of 11 antiretrovirals and 93% had a clinical history of triple class exposure (i.e. NRTIs, NNRTIs and PIs).
  • At entry, 93% of patients showed mutations associated with protease inhibitors (median of five) and 87% showed mutations associated with reverse transcriptase inhibitors (median of four).
  • Median baseline viral load: 79,400 copies/mL
  • Median baseline CD4+ cells: 70 cells/mm3
Results: Results at 16 weeks:
  • 60% (33/55) of patients had a decrease in viral load >1.0 log10 from baseline and/or achieved reduction in viral load to <400 copies/mL.
  • 36% (20/55) of patients achieved viral loads below limit of detection of Roche Amplicor Assay (<400 copies/mL).
Adverse Events: In all clinical studies to date, most adverse events reported on T-20 were mild or moderate in severity. The most frequent adverse events included fever, headache and lymph node abnormalities, in addition to local irritation resulting from the subcutaneous injection.
Conclusion: T-20, in combination with oral antiretrovirals, provides clinically relevant suppression of HIV through week 16 and may constitute a new treatment strategy for treating patients with prior antiviral experience.
Investigator: Jay Lalezari, M.D., Quest Clinical Research, San Francisco, CA
Contact: Lisa Fern, Burns McClellan, (212) 213-0006

Kellie McLaughlin, Hoffmann-La Roche, (973) 562-2231