Perez-Ancona F, Cano C, Lisker A, Montenegro A; International Conference on AIDS.

Int Conf AIDS. 1994 Aug 7-12; 10: 212 (abstract no. PB0278).

Depto. 65-1 Col. Pedregal de Carrasco, Coyoacan Mexico D.F.

OBJECTIVE: To evaluate the safety, tolerance and efficacy of zalcitabine (2.25 mg/d) plus ZDV (600 mg/d) in patients with advanced HIV-infection with CD4 counts of less than 300 cells/mm3. METHODS: Preliminary analysis includes 84 patients with AIDS or advanced HIV-infection (less than 300 CD4/mm3) who had received the combination regimen for six months. The safety of the therapy was evaluated with variance analysis by comparing the incidence of clinical adverse events, marked laboratory abnormalities, hematologic toxicities at entry vs those at 8, 12 weeks and 6 months of follow up. RESULTS: median age of the 84 patients included was 35.02 years, 7 were excluded for this analysis, 3 for neoplasias developed during the study (2 Kaposi sarcomas and 1 Non-Hodgkin linfoma), 1 patient died during week 10 due to causes not related to treatment (severe respiratory failure due to Pneumocystis pneumonia) and three were lost to follow up. 66 men and 11 women remain in the study and were considered for analysis, 64 (83%) acquired the infection through sexual contact and 13 through transfusion of blood or blood products. All 77 patients had received ZDV for an average of 17.8 months and the median CD4 count at entry was 160.8 cells/mm3. The most common adverse events were leukopenia in 26 occasions, anemia in 22, oral ulcers and rises in liver transaminases in 15 cases each. Other adverse events were nausea in 9 cases and transient erythema in 4. Only 3 patients developed peripheral neuropathy considered to be probable or possibly related to zalcitabine which was reversible after stopping the drug. Hyperamylasemia also occurred in three. Most adverse events occurred during the first 8 weeks of drug administration (48) and were reversible in all cases after temporarily reducing ZDV in 24 cases and zalcitabine in 8. CONCLUSIONS: zalcitabine plus ZDV in advanced HIV-infection is well tolerated up to this point with no serious adverse events, nevertheless there was a high incidence of myelotoxicity which led to reduction of ZDV in 24 patients (31.1%), this might indicate that Mexican patients with advanced HIV infection may show less toxicity with lower doses, specially when it is administered in combination. CD4 cell counts did not show any significant change. We need a longer follow up period in order to further evaluate the safety profile of this form of combination therapy.

Publication Types:

• Meeting Abstracts

Keywords:

• AIDS Vaccines
• Acquired Immunodeficiency Syndrome
• Antigens, CD4
• CD4 Lymphocyte Count
• Disease Progression
• Drug Therapy, Combination
• Female
• HIV Infections
• HIV Seropositivity
• Humans
• Incidence
• Male
• Pneumonia, Pneumocystis
• Sarcoma, Kaposi
• Zalcitabine
• Zidovudine
• drug therapy
• immunology
• therapy

Other ID:

• 94369735

UI: 102208561

From Meeting Abstracts