TreatmentUpdate 55 - Vol. 7, No. 1 - January 1995
Sean Hosein
For background information on DNCB please see TreatmentUpdate 43. We now report results from a long term observational study on DNCB. Researchers in California enrolled 24 male, HIV-infected subjects for this study;
- 18 subjects "had no symptoms" - 6 had persistently swollen lymph nodes - the average CD4+ cell count was 346 cells (ranging between 170 and 560 cells)
Subjects used a 'Q-tip' to dip into a 10% solution of DNCB which they then 'painted' on to a "2 inch square of skin" to see if they had been exposed to DNCB in the past. A month after first applying the 10% solution subjects began to use a 2% solution on a 2-inch square of their skin. If subjects then had a strong reaction-redness, itching-they used the weakest strength of DNCB that could cause a reaction on their skin.
* STOPPING USE OF THE DRUG
Eventually researchers found that 13 subjects continued to use DNCB on a regular basis while another 11 did not. Those subjects who stopped using DNCB did so after about 11 months. On average, researchers monitored subjects for over 2 years; some subjects were observed for almost 4 years. Two subjects also used a combination of AZT and ddC, two others AZT and ddI and seven others used AZT alone. Three subjects who used DNCB on a regular basis also took AZT.
* TOXICITY AND OTHER EFFECTS
Three subjects had side effects. The first had a rash over most of his body when he exercised right after his first DNCB patch. His reaction cleared in two hours. The other 2 subjects had very red and irritated reactions on the skin where they put a 10% solution of DNCB. Within 48 hours these reactions cleared. The study's researchers suggest that DNCB use appears to be "safe" in this small group of subjects. Three subjects noted that they had "significant" increases (no precise data provided) in their weight while using DNCB. According to the researchers, the weight gain did not appear to be caused by other drugs.
* SYMPTOMSOF HIV/AIDS
According to the researchers those subjects who stopped using DNCB after 11 months "appeared [more likely to develop] AIDS". None of these subjects stopped using DNCB because they became ill.
* CD4+CELLS
Both regular users of DNCB (who had 396 cells at the start of the study and 211 cells at the end) and non-users (who had 315 cells at the start of the study and 122 cells at the end) had decreased CD4+ cell counts. This difference between the 2 groups, with the DNCB users having a less severe decline, was statistically significant. The different CD4+ counts between the 2 groups at the start of the trial were not statistically significant.
* CD8+AND OTHER CELLS
Subjects who used DNCB on a regular basis had slightly increased levels of CD8+ (from 1014 to 1093 cells) and NK (natural killer) cells compared to subjects who did not take the drug on a regular basis (from 1234 to 920 cells). This difference between the 2 groups was statistically significant. At least 2 studies in the USA suggest that having a high CD8+cell count may mean that such subjects are less likely to die than subjects with less than 400 CD8+ cells. Researchers did not carry out any performance tests on CD8+ and NK cells taken from users of the drug. DNCB also appeared to increase certain types of CD8+ cells in users, but researchers are not sure just what this means.
* INFECTIONS/DEATHS
Researchers found that 2 of 13 subjects using DNCB on a regular basis developed skin lesions of KS (Kaposi's sarcoma). In one subject the lesion faded, in the other no new lesions appeared. No subject who continued to use the drug died. Five of 11 subjects who stopped using the drug developed AIDS; 3 had the life- threatening lung infection PCP; 2 had KS. These 5 subjects used DNCB for an average of 9 months and developed AIDS about 10 months after they stopped using the drug. Eventually 4 of the 5 subjects died. The researchers noted that all the subjects who developed ATDS used AZT and/or other anti-HIV drugs. This does not necessarily mean that AZT and related drugs may have been a factor in their deaths. These subjects may have been sicker at the start of the study and may have had a higher chance of dying than other subjects. Clearly larger and controlled studies of DNCB are needed to find out more about this drug's effects.
REFERENCES:
1. Stricker RB, Elswood BF, Goldberg B, et aL CEnical and immunologic evaluation of HIV-infected patients treated with dinitrochlorobenzene. Journal of the American Academy of Dermatology 1994;31(3)part 1:462-466
2. Giorgi JV, Ho HN, Huji K, et al. CD8+ lymphocyte activation of Human Immunodeficiency Virus seroconversion: development of HLA-DR+ CD38- CD8+ cells is associated with subsequent stable CD4+ levels. Journal of Infectious Diseases 1994;170:775-781.
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Copyright © 1995 - 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