5th Conference on Retroviruses and Opportunistic Infections


Chicago, IL - February 1-5, 1998



PRELIMINARY ASSESSMENT OF 141W94 IN COMBINATION WITH OTHER PROTEASE INHIBITORS

Conf Retroviruses Opportunistic Infect 1998 Feb 1-5; 5th:80 (abstract no. 6)

Eron J, Haubrich R, Richman D, Lang W, Tisdale M, Myers R, Pagano G, Rogers M
University of North Carolina, Chapel Hill, NC.

OBJECTIVE: To assess the safety, tolerance, and acute antiviral activity of combination HIV protease inhibitor therapy in HIV infected subjects with greater than 200 CD4+ cells/mm3 and HIV RNA greater than 10,000 copies/mL.

METHODS: Eligible adults with no prior HIV protease inhibitor exposure were randomized to receive 141W94 800 mg TID plus one of the following: saquinavir (soft gel cap (SQV)) 800 mg TID, indinavir (IDV) 800 mg TID, nelfinavir (NLF) 750 mg TID. A fourth cohort received 141W94 alone for 3 weeks followed by the addition of zidovudine 300 mg BID + 3TC 150 mg BID.

RESULTS: 27 patients have been enrolled. The majority of subjects are white males with a median age of 39.1 years. Viral load data are available for 16 subjects at week 4.

Log10 HIV RNA Copies/mL Week 2 Log10 HIV RNA Copies/mL Week 4
Group N Baseline
Median		 Median Change
from Baseline**		 N Baseline
Median		 Median Change
from Baseline**
SQV+141 5 4.66 -1.83 3 4.45 -2.53
IDV+141 6 5.06 -2.30 5 5.14 -2.57
NLF+141 3 4.73 -2,54 4 4.88 -3.18
141* 3 4.09 -1.32 4 4.26 -1.74
*AZT+3TC added at week 3. **Lower limit of detection of HIV RNA assay was 40 copies/mL

The combinations were well tolerated and had potent antiviral activity. 13/16 subjects had a decrease in viral load to less than 400 copies/mL by week 4. The most common adverse events were diarrhea, perioral tingling/numbness, nausea, rash, headache and flatulence. Evaluation of pharmacokinetic data is ongoing.

CONCLUSIONS: During the initial 4 weeks of this study, the combinations were generally well tolerated and had significant antiviral activity. Continued investigation of these combinations is ongoing.

Keywords: AEGIS, HIV Protease Inhibitors, Nelfinavir, Indinavir, Saquinavir, Lamivudine, Anti-HIV Agents, Zidovudine, Reverse Transcriptase Inhibitors, Viral Load, Sulfonamides, HIV Infections, HIV, Sulfonic Acids, VX 478, 4-trimethylammonium-4′-isothiocyanostilbene-2,2′-disulfonic, acid, Human, Male, Adult, AIDS

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1998-02-01
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Copyright © 1998 - Foundation for Retrovirology and Human Health (IAS). Reproduction of this abstract (other than one copy for personal reference) must be cleared through the Foundation for Retrovirology and Human Health. Licensed from National Library of Medicine.