The pharmacokinetics and safety of zidovudine in the third trimester of pregnancy for women infected with human immunodeficiency virus and their infants: Phase I Acquired Immunodeficiency Syndrome Clinical Trials Group study (protocol 082)

OʼSullivan, Mary J.; Boyer, Pamela; Scott, Gwendolyn B.; Parks, Wade P.; Weller, S; Blum, Martin; Balsley, James; Bryson, Yvonne J.

doi:10.1016/s0002-9378(11)90791-1

Cited by 152 publications

(46 citation statements)

References 12 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…The pharmacokinetics of zidovudine were also monitored 3-4 weeks post partum and at that time the pharmacokinetic par ameters were no longer different from those re ported in HIV-infected men. In another study, pharmacokinetic parameters during pregnancy were similar to those reported in HIV-infected men [22]. It should be noted that this comparison does not account for any influence of sex on the clearance of zidovudine.…”

Section: Absorptionsupporting

confidence: 64%

“…Zidovudine distribution into saliva [20] is of particular interest because the ease of collection and avoidance of blood handling could make saliva a favourable matrix for therapeutic drug monitoring. Zidovudine crosses the placenta and has been measured in neonatal blood [21][22][23]. It is not yet known whether pregnancy affects the pharmaco kinetics of zidovudine.…”

Section: Absorptionmentioning

confidence: 99%

See 1 more Smart Citation

Concise overview of the clinical pharmacokinetics of dideoxynucleoside antiretroviral agents

1995

View full text Add to dashboard Cite

In this paper aspects of the clinical pharmacokinetics of the antiretroviral agents zidovudine, didanosine and zalcitabine are reviewed. Special attention is paid to possibly altered pharmacokinetics in special circumstances, such as hepatic and renal dysfunction, pregnancy, stage of disease, etc, The dideoxynucleoside antiretroviral agents have some clinical pharmacokinetic properties in common (rapid absorption and elimination), but substantial differences exist in their degree of absorption, metabolism and penetration into the cerebrospinal fluid. All agents display wide interpatient variability in pharmacokinetic parameters. The relevance of therapeutic drug monitoring of antiretroviral agents is also discussed.

show abstract

Section: Absorptionsupporting

confidence: 64%

Section: Absorptionmentioning

confidence: 99%

Concise overview of the clinical pharmacokinetics of dideoxynucleoside antiretroviral agents

1995

View full text Add to dashboard Cite

show abstract

“…Although zidovudine did not always prevent vertical transmission of HIV (36), some studies showed that vertical transmission was not observed in a total of 11 cases who had been given zidovudine during pregnancy (37,38). These highly promising data, though preliminary, had been available at the time of protocol development of the PACTG 076 study (39).…”

Section: Questions From the View Of Contextual Featurementioning

confidence: 99%

Ethical Considerations in Clinical Trials in Asia

Tanida

2002

Drug Information J

View full text Add to dashboard Cite

Instances of clinical trial misconduct are usually due to insufficient analysis of medical indications, ignoring patient preferences, and the way in which investigators assess clinical trial results. Those problems are subjects of universal concerns. In the context of clinical trials, these are subjects inherent not only in Asia but also in every society, i.e., the "specific needs of each society." Therefore, if there is any Asia-specific ethics, it is the issue of who will benefit from clinical trials or to consider the specific needs and benefits of Asian people.

show abstract

“…Of the currently approved nucleoside analogue antiretroviral agents, the pharmacokinetics of only ZDV and 3TC have been evaluated in infected pregnant women to date (27,28). Both appear to be well tolerated at the usual adult doses and cross the placenta, achieving concentrations in cord blood similar to those observed in maternal blood at delivery.…”

Section: Considerations For Antiretroviral Therapy In the Hiv-infectementioning

confidence: 99%

Guidelines for the Use of Antiretroviral Agents in HIV-Infected Adults and Adolescents

1998

Ann Intern Med

801

View full text Add to dashboard Cite

SummaryThe availability of an increasing number of antiretroviral agents and the rapid evolution of new information has introduced extraordinary complexity into the treatment of HIV-infected persons. In 1996, the Department of Health and Human Services and the Henry J. Kaiser Family Foundation convened the Panel on Clinical Practices for the Treatment of HIV to develop guidelines for the clinical management of HIV-infected adults and adolescents.This report recommends that care should be supervised by an expert, and makes recommendations for laboratory monitoring with particular emphasis on measurement of plasma levels of HIV RNA. The report also provides guidelines for antiretroviral therapy, including when to start treatment, what drugs to initiate, when to change therapy, and therapeutic options when changing therapy. Special considerations are provided for adolescents and pregnant women. As with treatment of other chronic conditions, therapeutic decisions require a mutual understanding between the patient and the health care provider regarding the benefits and risks of treatment. Like the treatment of most chronic diseases, antiretroviral regimens are complex, have major side effects, pose difficulty with compliance, and carry serious potential consequences with the risk of resistance from non-adherence to the drug regimen or suboptimal levels of antiretroviral agents. Patient education and involvement in therapeutic decisions is important for all medical conditions, but is considered especially critical for HIV infection and its treatment.With regard to specific recommendations, treatment should be offered to all patients with the acute HIV syndrome, those within six months of seroconversion, and all patients with symptoms ascribed to HIV infection. Recommendations for offering antiretroviral therapy in asymptomatic patients depend on virologic and immunologic factors. In general, treatment should be + 3 offered to individuals with fewer than 500 CD4 T cells/mm or plasma HIV RNA levels exceeding 10,000 copies/ml (bDNA assay) or 20,000 copies/ml (RT-PCR assay). The strength of the recommendation to treat asymptomatic patients should be based on the patient's willingness to accept therapy, the probability of adherence with the prescribed regimen, and the prognosis in terms of time to an + AIDS-defining complication as predicted by plasma HIV RNA levels and CD4 T cell counts, which independently help to predict prognosis. Once the decision has been made to initiate antiretroviral therapy, the goal is maximum viral suppression for as long as possible. Results of clinical trials to date indicate that this may currently be best achieved with a potent protease inhibitor (PI) in combination with two nucleoside analogue reverse transcriptase inhibitors (NRTIs). Another option is the combination of saquinavir plus ritonavir combined with one or two NRTIs. Other currently available regimens may be used in selected settings, but are considered by many to be less likely to produce maximum viral suppression. Results of t...

show abstract

The pharmacokinetics and safety of zidovudine in the third trimester of pregnancy for women infected with human immunodeficiency virus and their infants: Phase I Acquired Immunodeficiency Syndrome Clinical Trials Group study (protocol 082)

Cited by 152 publications

References 12 publications

Concise overview of the clinical pharmacokinetics of dideoxynucleoside antiretroviral agents

Concise overview of the clinical pharmacokinetics of dideoxynucleoside antiretroviral agents

Ethical Considerations in Clinical Trials in Asia

Guidelines for the Use of Antiretroviral Agents in HIV-Infected Adults and Adolescents

Contact Info

Product

Resources

About