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Pre-Clinical & Clinical
4th International Congress on Drug Therapy in HIV Infection
Glascow UK
8-17 November 1998
AIDS 12-4: P240 (1998)

THE PHASE I OF THE CLINICAL OF PHOSPHAZID THE NEW REVERSE TRANSCRIPTAZE INHIBITOR
Yurin O., Kravtchenko A., Serebrovskaya L., Golochvastova E., Burova N., Voronin E., Pokrowsky V.

1. Russia AIDS Federal Centre, kopr.2, d.15, 8-ya, Ulitsa Sokolinoy Gory, Moscow, 105275, Russia.
2. Moscow Municipal Infectious Hospital N2
3. Federal Infectious Hospital

Purpose of the study:
To provide the primary estimation of the tolerance and the efficiency of Phosphazid (PhAZT), the new antiretroviral drug derevated from azydothimidin (AZT). As the preclinical study demonstrated, PhAZT has the same antiretroviral activity but significantly lesser toxicity compared with AZT.

Methods:
The clinical and immunological (CD4 cells level) observation during 12 weeks for 3 groups of HIV+ adults, 25 patients (group 1) received PhAZT in the daily dose of 0.6g, 30 patients (group 2) received AZT in the same doze and 30 patients (group 3) refused to receive any antiretroviral therapy. All of the 85 patients were in clinical category A2 by CDC classification.

Summary of results:
The serious adverse events were not observed. The adverse events related with the therapy were observed in 1 (4%) patient from group 1 (slight nausea) and in 4 (13%) patients from group1 (weakness, nausea, vomiting) (P>0.05). 3 patients, who previously can not receive the treatment by AZT because of nausea and vomiting, do not develop these manifestations during the treatment by PhAZT.

THE DYNAMICS OF THE MEAN NUMBER OF CN4 + CELLS (109/L)

  Weeks of Therapy P 0/4 P 0/8 P 0/12
  0 4 8 12      
Group 1 0.32 0.38 0.41 0.43 >0.05 >0.05 <0.05
Group 2 0.33 0.37 0.42 0.42 >0.05 <0.05 <0.05
Group 3 0.33 - - 0.31     >0.05

Conclusions:
The first results of the clinical trails of Phosphazid showed the good tolerance of the possible efficiency. The providing of the second phase of the trials is perspective.

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