TreatmentUpdate 75: January 1997 - Volume 9, Number 1
Sean Hosein
Researchers in Mexico enrolled 28 adults (2 female, 26 male) who had suffered HIV-related weight loss. This problem occurred despite the use of AZT and related drugs (protease inhibitors were not available). None of the study volunteers had active, life-threatening infections at the time they entered the study, although they used drugs to suppress such infections before and during the trial. Since some of the subjects in this study were going to receive thalidomide, doctors did not want them using other drugs that could also weaken the immune system, specifically:
By the end of the 12th week, 9 subjects receiving placebo and only one subject receiving thalidomide had lost weight. Eight subjects in the thalidomide group and 3 others stopped losing weight. No data is available about the 3 remaining subjects because 2 left the study due to drug toxicity and one had failed to take his medication as directed. After these withdrawals there were 11 people left in the thalidomide group. According to the study doctors, these 11 subjects took at least "80%" of the thalidomide given to them.
Subjects given placebo were three times more likely to experience continued weight loss than subjects who received thalidomide. This was statistically significant; that is, likely due to the effect of thalidomide and not chance.
By the 12th week of the study, 50% of subjects on thalidomide had gained 4 kg. Of this, one kilogram was muscle. Meanwhile, 50% of subjects on placebo lost about 1 kg of weight, most of which was muscle. These differences between the two groups were statistically significant.
No one died while in the study. In fact, 10 subjects on thalidomide and 9 on placebo did not develop any life-threatening complications. Diarrhea, however, was a problem for 5 subjects, 2 on thalidomide and 3 on placebo. Readers should note that several subjects had diarrhea before entering the study. The germs that caused diarrhea were the following:
All subjects receiving thalidomide felt sleepy at times. This is not surprising given that thalidomide was developed as a mild sedative. A similar effect was seen in only 5 people on placebo. This difference between the two groups was statistically significant.
Eleven subjects who received thalidomide developed "skin rash," compared to only 3 subjects on placebo. One of the subjects on thalidomide had a rash so severe that he nearly died.
One subject on thalidomide developed painful nerves in the feet/hands.
Five subjects on thalidomide experienced constipation. One factor to consider is that some of these people had diarrhea and were using other drugs to reduce its severity, which may have contributed to the constipation.
Four subjects on thalidomide had this side effect.
In summary, taking 400 mg/day of thalidomide for 3 months stopped weight loss and even helped some PHAs gain weight, 25% of which was muscle. Thalidomide did not affect levels of HIV, CD4+ or CD8+ cells. The drug was however associated with several side effects, including:
While the results from this study are promising, there are several questions left unanswered:
1. Reyes-Terán G, Sierra-Madero JG, Del Cerro VM, et al. Effects of thalidomide on HIV-associated wasting syndrome: A randomized, double-blind, placebo-controlled clinical trial. AIDS;10(13): 1501-1507.
970120
CATE7501
Copyright © 1997 - 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
Disclaimer: The editors have taken all such care as they consider reasonable in preparing this database, but they cannot be held responsible for any inaccuracies or mis-statements of fact contained herein. Inclusion in this database of any information on any treatment, therapy, or clinical trial in no way represents an endorsement of that treatment, therapy, or trial by ÆGiS or any of its sponsors. This data should always be used in conjunction with professional medical advice.