TreatmentUpdate 76. 9(2): 5-6; March, 1997
Sean Hosein

Study details

For this study doctors in France recruited 144 HIV-infected subjects (33 female, 111 male), 50% of whom had AIDS. More than half the subjects had used AZT, ddC, ddI and/or 3TC while 33% had used d4T before entering the study. All subjects received antibiotics to prevent PCP and, in some cases, the life-threatening brain infection toxo (toxoplasmosis), as well as MAC (Mycobacterium avium complex). Once in the study, 50% of subjects received d4T (80 mg/day if they weighed 60 kg or more, or 60 mg/day if they weighed less than 60 kg), 3TC 300 mg/day and indinavir 2.4 g/day. At the start of the study 50% of subjects had:

* 69 CD4+ cells

* a viral load of 43,000 copies

Results ? HIV and CD4+

On average, subjects gained about 3 kg of weight. By the 2nd month, half the subjects had:

* a CD4+ count of 140 cells

* a viral load of 427 copies

By the 6th month, 50% of subjects had:

* a CD4+ cell count of 164 cells

* a viral load of 316 copies.

Results ? deaths

By the 6th month of the study, 3 subjects had died; one from heart problems, another from severe weight loss and MAC infection, and a third from a combination of ?reactivated lymphoma?, CMV and a bacterial infection. Another 4 subjects developed life-threatening complications commonly seen in AIDS.

Toxicity

At least 18 subjects had stop taking their drugs to temporarily because of side effects, including;

* pain in the hands/feet (9 subjects)

* kidney stones (4)

* nausea/diarrhea/intestinal pain (3)

* liver damage (2)

Subjects who developed peripheral neuropathy while on d4T had this problem clear when they switched to AZT.

Despite these promising results, researchers found that even after 6 months of triple therapy 44% of subjects had only a small decrease in the viral load. Researchers think that half of the 44% did not take their drugs as directed.

REFERENCES:

1. de Truchis P, Zucman D, Dupont AM, et al. Combination therapy with d4T + 3TC + indinavir (IDV) in nucleoside-experienced HIV-infected patients: an open study. Poster 247.

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