|Evaluation of the quality of life associated with zidovudine treatment in asymptomatic human immunodeficiency virus infection. The AIDS Clinical Trials Group.|| ||Lenderking WR, Gelber RD, Cotton DJ, Cole BF, Goldhirsch A, Volberding PA, Testa MA
| ||"The trial compared treatment with 500 mg of zidovudine per day, 1500 mg of zidovudine per day, and placebo (Protocol 019) in 1338 asymptomatic HIV-infected patients... The average time with neither a progression of disease nor an adverse event (symptom or laboratory finding) was 15.7, 15.6, and 14.8 months for patients receiving placebo, 500 mg of zidovudine, and 1500 mg of zidovudine, respectively. The incidence of severe symptoms was 13.8 percent in the placebo group, 15.2 percent in the 500-mg group, and 19.9 percent in the 1500-mg group (P = 0.038)..."|
| ||N Engl J Med 1994 Mar 17;330(11):738-43||1994|
|Drug Information for the Health Care Professional|| ||No author
| ||"Because of the complexity of this disease state, it is often difficult to differentiate between the manifestations of HIV infection [sic] and the manifestations of zidovudine (AZT). In addition, very little placebo controlled data is available to assess this difference".|
| ||United States Pharmacopeia's USP DI, 1996, pages 3032-3034||1996|
|Rapid disease progression in HIV-1 perinatally infected children born to mothers receiving zidovudine monotherapy during pregnancy. The Italian register for HIV Infection in Children|| ||Anonymous
| ||To investigate the outcome in children perinatally infected with HIV-1 whose mothers received zidovudine (ZDV) monotherapy in pregnancy. Observational retrospective study of a prospectively recruited cohort. SETTING: Italian Register for HIV Infection in Children. A group of 216 children perinatally infected with HIV-1, born in 1992-1997 and derived prospectively from birth: 38 children had mothers receiving ZDV monotherapy and for 178 children the mothers received no antiretroviral treatment during pregnancy. The estimated probability of developing severe disease or severe immune suppression, survival probability [95% confidence interval (CI)] within 3 years, and the hazard ratio (95% CI), adjusted for year of birth, maternal clinical condition at delivery, birthweight and treatments (Pneumocystis carinii pneumonia chemoprophylaxis and/or antiretroviral therapy before the onset of severe disease, severe immune suppression or death) were compared. Comparison of HIV-1-infected children whose mothers were treated with ZDV with children whose mothers were not treated showed that the former group had a higher probability of developing severe disease [57.3% (95% CI 40.9-74.3) versus 37.2% (95% CI 30.0-45.4); log-rank test 7.83, P = 0.005; adjusted hazard ratio 1.8 (95% CI 1.1-3.1)] or severe immune suppression [53.9% (95% CI 36.3-73.5) versus 37.5% (95% CI 30.0-46.2); log-rank test 5.58, P = 0.018; adjusted hazard ratio 2.4, (95% CI: 1.3-4.3)] and a lower survival [72.2% (95% CI 50.4-85.7) versus 81.0% (95% CI 73.7-86.5); log-rank test 4.23, P = 0.039; adjusted hazard ratio of death 1.9 (95% CI 1.1-3.6)].|
| ||AIDS, 1999, 13:927-933.||1999|
|Prolonged pancytopenia due to combined ganciclovir and zidovuduine therapy|| ||Jacobson M A, de Miranda P, Gordon S M, Blum M R, Volberding P and Mills J
| ||No abstract / Pubmed|
| ||J. Infect. Dis. 1988, 158 489–490||1988|
|Caution: should we be treating HIV infection early?|| ||Levy JA.
| ||“These drugs can be toxic and can be directly detrimental to a natural immune response to HIV…”|
| ||Lancet. 1998 Sep 19;352:982-3.||1998|
|Potential molecular competitor for HIV.|| ||Scolaro M, Durham R, Pieczenik G.
| ||Ten out of 11 HIV-positive, AZT-treated AIDS patients recovered cellular immunity after discontinuing AZT in favour of an experimental vaccine|
| ||Lancet 1991; 337: 731-732.||1991|
|Natural History of Vertically Acquired Human Immunodeficiency Virus-1 Infection.|| ||European Collaborative Study
| ||The study reports that over 60% of congenitally-infected children were healthy at 6 years after birth although many had experienced transient AIDS diseases, such as pneumonia, bacterial infections, candidiasis and cryptosporidial infection during the first year after birth. About 20% of the HIV-positive children had died or developed long-term AIDS during the first year after birth, and another 20% during the second and third years and that is exactly the percentage that was "treated with zidovudine [AZT]", 10% before 6 months of age and 40% by 4 years.|
| ||Pediatrics 1994; 94: 815-819.||1994|
|Different immunologic profiles characterize HIV infection in highly active antiretroviral therapy-treated and antiretroviral-naive patients with undetectable viraemia.|| ||Clerici M et al.
| ||“Our results show that immune responses are potent in antiretroviral-naive but significantly reduced in HAART-treated patients with undetectable viraemia (< 500 copies/ml)...T-cell proliferation to HIV-specific and HIV-unrelated antigens is potent in antiretroviral-naive but suppressed in HAART-treated individuals. HAART is associated with weaker HIV-specific and -non-specific immune responses”|
| ||AIDS. 2000 Jan 28;14:109-116.||2000|
|Natural history of somatic growth in infants born to women infected by human immunodeficiency virus.|| ||Moye J, Rich KC, Kalish LA, Sheon AR, Diaz C, Cooper ER, Pitt J, Handelsman E, for the Women and Infants Transmission Study Group.
| ||The National Institutes of Child Health and Development : "Zidovudine use is confounded by progression of HIV disease". The study reports that during the first 18 months after birth a group of HIV-positive babies lagged on average behind a control group of HIV-free infants in all developmental parameters. But the study also reports intravenous and other drug use by the mothers, and that "up to 60% at 18 months" of HIV-posities were on AZT. By 18 months 40% of the HIV-positive babies had apparently completely recovered from maternal drugs, despite HIV, because they were nor treated with AZT nor were any deaths reported. However, up to 60% apparently had suffered intermittent diseases from AZT and residual damage of maternal drug use. Thus the normal performance of 40% of the HIV-positive group, 18 months after withdrawl from maternal drugs, was hidden by the subnormal performance of the HIV-group that was an average of AZT recipients and untreated babies|
| ||The Journal of Pediatrics 1996; 128: 58-67.||1996|
|Toxicities Associated with Purine Analog Therapy|| ||Cheson Bruce D
| ||The nucleoside analogs have proven to be highly effective in the therapy of lymphoid malignancies. However, they have a number of associated toxicities, some of what may be severe. Of particular concern is immunosuppression which is uniform with standard treatment programs. Each of the nucleoside analogs is associated with a profound lymphocytopenia, with a reversal of the CD4/CD8, and opportunistic infections. Whether secondary malignancies will be a long-range complication will require observation and recording of long-term follow-up resulsts.The frequency with wich many of the nonhematologic toxicities occur is difficult to estimate. Most studies contain small numbers of patients, in whom few, if any nonhematologic toxicities are reported. Whether that reflects the actual rarity of these events or the care with which those series was evaluated is not clear. As the clinical experience with these agents become more extensive, with longer follow-up, recognized toxicities will become better charatrized and new side effects ma be encountered. Anecdotal reports may serve to increase the sensitivity for identification of new and unusual complications.|
| ||Nucleoside Analogs in Cancer Therapy, edited by Bruce D. Cheson, Michael J. Keating, William Plunkett, Marcel Dekker Inc. New York, Basel, Hong Kong 1997||1997|
|Physician's Desk Reference|| ||No author
| ||"It is often difficult to distinguish adverse events possibly associated with Zidovudine administration from underlying signs of HIV disease or intercurrent illness."|
| ||Thomson Healthcare||1992|