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The Body Covers: The 6th Conference on Retroviruses and Opportunistic Infections
Abstract No. 489: ACTG 364: Virologic Efficacy of Nelfinavir (NFV) and/or Efavirenz (EFZ) in Combination with New Nucleoside Analogs in Nucleoside Experienced Subjects

February 3, 1999

A note from TheBody.com: Since this article was written, the HIV pandemic has changed, as has our understanding of HIV/AIDS and its treatment. As a result, parts of this article may be outdated. Please keep this in mind, and be sure to visit other parts of our site for more recent information!

Scott Hammer presented data from ACTG 364, a "rollover" study from an earlier NIH trial. This is a Phase II, randomized, trial designed for nucleoside reverse transcriptase inhibitor (NRTI) experienced patients. There were three treatment arms comparing nelfinavir (NFV) and/or efavirenz (EFZ) in combination with two nucleoside analogs. This important study points the way to effective regimens (so-called "salvage regimens") even for patients who have been heavily pre-treated. Each patient with a viral load above 500 copies was assigned to Treatment Group A and received, in an open-label fashion at least 1, and if possible 2, new NRTIs. Each patient was then randomized, in a double-blind fashion, to one of three possible arms featuring either NFV and/or EFZ, as follows:


Treatment Group A
ARM I: NFV + EFZ placebo + 2 NRTIs
ARM II: NFV placebo + EFZ + 2 NRTIs
ARM III: NFV + EFZ + 2 NRTIs


The possible dual NRTI combinations were ddI/d4T, ddI/3TC, or d4T/3TC.

Subjects with viral loads below 500 copies were assigned to Treatment Group B and remained on their originally assigned ACTG 302/303 dual nucleoside analog therapy. A total of 195 patients were in Treatment Group A, while 41 people were in Treatment Group B. The patients' baseline median viral load was 7776 copies and mean CD4 (T-cell) count was 389 cells. Of the 195 patients on Treatment Group A, 66 were on the NFV+NRTIs arm, 65 were on the EFZ+NRTIs arm, and 64 were on the NFV+EFZ+NRTIs arm.

A total of 33 patients, or 17%, discontinued study participation during the 52 week follow-up period. The majority of the dropouts were due to treatment failure: 20 (61%) of the 33 patients (61%) had their viral load rise above 2,000, and one patient developed lymphoma. Additionally, 2 patients died while on study. One death was attributed to respiratory failure (this death occurred in the NFV arm at week 40) and the other death was a result of pancreatitis and multi-organ failure. This was reported in the EFZ arm at week 28.

Overall, 106 of 189 patients (56%) across all treatment arms at week 40-48 enjoyed viral load decreases by weeks 40-48, with the individual regimen breakdown as follows:


Percentage of patients
below 500 copies
NFV: 35%
EFZ: 60%
NFV + EFV: 74%


This result was highly statistically significant, with the NFV+EFV arm providing the most powerful anti-HIV activity, even in this highly experienced population. With regard to T-cell count increases, there were no significant differences among the three treatment arms at week 40-48, with patients enjoying a median increase of 94 cells.

A note from TheBody.com: Since this article was written, the HIV pandemic has changed, as has our understanding of HIV/AIDS and its treatment. As a result, parts of this article may be outdated. Please keep this in mind, and be sure to visit other parts of our site for more recent information!

Abstract: ACTG 364: Virologic Efficacy of Nelfinavir (NFV) and/or Efavirenz (EFZ) in Combination with New Nucleoside Analogs in Nucleoside Experienced Subjects
Authored by: M. Albrecht, D. Katzenstein, R. Bosch, S. Liou, S. Hammer for the ACTG 364 Study Team

See Also
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