Important note: Information in this article was accurate in September 2000. The state of the art may have changed since the publication date.
About four years ago researchers began a study comparing the effect of different combinations of anti-HIV drugs. In one group of that study subjects received a combination of indinavir (Crixivan), AZT and 3TC. Researchers have been monitoring subjects taking that combination for three years and have published their results. That people are able to successfully take a complex regimen for three consecutive years is amazing. The results regarding side effects will be of particular interest to readers.
Before entering this study, subjects had been exposed to AZT but never 3TC nor protease inhibitors. Researchers originally recruited 33 adult HIV-positive subjects (2 female, 31 male). At the start of the study the group had the following lab values:
Although 33 people entered the study, 12 left for the following reasons:
The proportion of subjects whose viral load was below the 50 copy mark was as follows:
Compared to their pre-study levels, subjects had the following increase in their CD4+ cell counts:
Nine subjects developed rising viral loads during the study. In analysing the type of virus in these subjects, technicians detected HIV that was resistant to 3TC. Five subjects developed resistance to indinavir and six entered the study with AZT-resistant virus.
Due to the prolonged exposure to indinavir, perhaps it is not surprising that some people developed kidney stones and related complications such as pain and problems urinating. The following proportion of subjects developed kidney stones during the study:
As many as 21% developed more than one episode of kidney stones. The figure of 36% mentioned previously, is much higher than seen in earlier studies of indinavir. Drinking 1.5 litres of liquid/day, in addition to whatever subjects normally drink, may not be enough fluid for long-term indinavir users.
Nearly 20% of subjects developed changes in their body shape while in the study. Lab tests detected increased levels of fat in the blood of subjects. One subject developed higher-than-normal levels of sugar in his/her blood.
Subjects in this study were very adherent to their medication schedule.
That they were able to take indinavir every eight hours, for three consecutive years is no mean feat. The drug has a demanding regimen with food restrictions as well as a requirement for a huge intake of liquid.
These requirements may make indinavir, taken three times daily, unsuitable for some PHAs. This is why researchers are conducting experiments with twice daily regimens of indinavir together with other protease inhibitors.
More news about indinavir combinations will appear in a future issue of TreatmentUpdate.
1. Glulick RM, Mellors JW, Havlir D, et al. 3-year suppression of HIV viremia with indinavir, zidovudine, and lamivudine. Ann Intern Med 2000 Jul 4;133(1):35-9.
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