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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 |
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