A pilot study to evaluate the safety and feasibility of the administration of AZT/3TC fixed dose combination to HIV infected pregnant women and their infants in Rio de Janeiro, Brazil

• Published in: Sexually transmitted infections Vol. 79; no. 6; pp. 448 - 452
• Main Authors: Lambert, J S, Nogueira, S A, Abreu, T, Machado, E S, Costa, T P, Bondarovsky, M, Andrade, M, Halpern, M, Barbosa, R, Perez, M
• Format: Journal Article
• Language: English
• Published: London BMJ Publishing Group Ltd 01-12-2003; BMJ; BMJ Publishing Group LTD; BMJ Group
• Subjects: Administration, Oral; Adult; Age; Anti-HIV Agents - administration & dosage; Antiretroviral drugs; Antiviral agents; Babies; Biological and medical sciences; Brazil; CD4 Lymphocyte Count; Children & youth; Clinical trials; Complications and side effects; Diseases; Dosage and administration; Drug dosages; Drug therapy; Drug Therapy, Combination; Feasibility studies; Female; General aspects; Gynecology. Andrology. Obstetrics; Health aspects; Hematology; HIV; HIV infection; HIV Infections - drug therapy; Human immunodeficiency virus; Human infectious diseases. Experimental studies and models; Humans; Infant, Newborn; Infections; Infectious diseases; Laboratories; Lamivudine; Lamivudine - administration & dosage; Medical sciences; mother to child transmission; Neutrophils; Newborn babies; Original; paediatric AIDS; Pilot Projects; Postpartum period; Pregnancy; Pregnancy Complications, Infectious - drug therapy; Pregnant women; Tropical medicine; Ultrasonic imaging; Viral Load; Womens health; Zidovudine; Zidovudine - administration & dosage; South America; Brazil; America; Human; Immunopathology; Toxicity; Lamivudine; Infant; AIDS; Immune deficiency; Infection; Pregnancy; Chemotherapy; Sexually transmitted disease; Treatment; Viral disease; Antiviral; Female; Feasibility; Safety; Azathioprine; Woman; Dose
• ISSN: 1368-4973; 1472-3263
• DOI: 10.1136/sti.79.6.448

Objectives: To evaluate the safety and feasibility of zidovudine and lamivudine (AZT/3TC) given to HIV infected pregnant women and their infants in Rio de Janeiro, Brazil. Methods: This open label phase II study enrolled 40 HIV infected antiretroviral naive women ⩾20 weeks gestation, CD4 <500 cells ×106/l, from two public hospitals. Treatment: fixed dose AZT 300 mg/3TC 150 mg by mouth every 12 hours until labour; AZT 300 mg by mouth every 3 hours until delivery; infants: AZT 4 mg/kg every 12 hours plus 3TC 2 mg/kg every 12 hours for 6 weeks. Blood haematology and chemistry were monitored; adherence evaluated by pills count; efficacy measured by changes in lymphocyte (CD4) and viral load, and by HIV RNA-PCR tests performed at birth, 6 and 12 weeks, to diagnose infant infection. No women breast fed. Results: Patient characteristics: mean age 24.48 (SD 3.5) years; gestational age 24.5 (4.5) weeks; AZT/3TC duration 14.4 (4.4) weeks; vaginal delivery: 11/39; caesarean section: 28/39. Entry and pre-labour CD4: 310/486 cells ×106/l (p<0.001); entry and pre-labour viral load: 53 818/2616 copies/ml (p<0.001). Thirty nine women tolerated treatment with >80% adherence; one was lost to follow up. Five newborns were excluded from 3TC receipt. All 39 babies were uninfected. Haematological toxicity in newborns was common: anaemia in 27; neutropenia in five (two severe); platelets counts <100 000 in two. All values recovered on study completion. Conclusions: Fixed dose AZT/3TC is well accepted, gives improvements in CD4 and viral load; no infants were HIV infected. Haematological toxicity in infants needs careful monitoring.