AEGiS-CATIE: ANTI-HIV AGENTS: Indinavir and IL-2 -- one year later

ANTI-HIV AGENTS: Indinavir and IL-2 -- one year later

TreatmentUpdate 71, Volume 8, No 7; October 1996
Sean Hosein

Interleukin-2 (IL-2) is a chemical produced by the immune system that can have a number of effects, one of which is helping T cells grow. IL-2 can also increase production of HIV by infected cells, so in experiments on HIV-infected subjects, researchers always use anti-HIV drugs with IL-2.

In this experiment researchers recruited 36 HIV-infected subjects who had less than 300 CD4+ cells or 20% CD4+ cells. The subjects were then divided into three groups:

* Group A: 13 subjects received by injection IL-2 up to 12 million units (12 MU) per day for "5 days every 2 months" and indinavir 600 mg every 6 hours.

* Group B: 11 subjects received the same dose and schedule of IL-2 as group A. As well, they received indinavir 600 mg/6 hours only for 10 days every 2 months before, during and after they received IL-2.

* Group C: 12 subjects received indinavir 800 mg every 8 hours for the duration of the study.

Results

The first part of this study lasted for 14 weeks. Below are the average CD4+ cell counts before subjects began to use the study drugs, followed by the counts at the 14th week:

* Group A -- 205 and 363 cells

* Group B -- 191 and 246 cells

* Group C -- 144 and 230 cells

We list below the decrease in HIV levels in the blood of subjects by the 14th week:

* Group A -- 1.5 times less HIV

* Group B -- 1.2 times less HIV

* Group C -- 5 times less HIV

After the 14th week subjects were allowed to add other anti-HIV drugs to their regimens and subjects in group C could also use IL-2. About one year after entering the study fewer subjects remained and only 8 subjects in each group were receiving IL-2. By this time the average CD4+ cell counts were:

* Group A -- 536 cells, 9 subjects

* Group B -- 386 cells, 8 subjects

* Group C -- 302 cells, 12 subjects

Toxicity and lack of effect

Subjects experienced "typical" side effects from use of IL-2 (fever, headache, muscle/joint pain, fatigue), and at least 2 subjects developed kidney stones. During the first year of the study no subjects died. In the 2nd year one subject developed PCP and 1 subject not receiving IL-2 developed dementia. Four subjects in group A, 2 in group B and 2 in group C stopped using IL-2 because it did not increase their CD4+ cell counts.

Interpretation

The use of indinavir and IL-2 caused a small decrease in the viral load and also increased CD4+ cell counts. Use of combination anti-HIV therapy together with IL-2 may be useful in the long term.

REFERENCES:

1. Falloon J, Owen C, Metcalf C, et al . Indinavir and IL-2 in HIV: one year follow up. Abstract I108.

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Copyright © 1996 - TreatmentUpdate. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Editor, The Canadian AIDS Treatment Information Exchange, 555 Richmond St. West, Suite 505, Box 1104, Toronto, ON, M5V 3B1 • Phone: 416-203-7122 • Toll Free: 1-800-263-1638 • Fax: 416-203-8284 http://www.catie.ca

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©1996. AEGIS.