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

Lambert, John S.

doi:10.1136/sti.79.6.448

Cited by 19 publications

(12 citation statements)

References 25 publications

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“…[24][25][26][27] Similar to our study, other zidovudine-containing PMTCT trials demonstrate that infants exposed to zidovudine in utero show lower hemoglobin levels compared with unexposed infants but that these declines do not persist or lead to adverse clinical outcomes. [24][25][26][27][28][29][30] An important difference between this Indian study and prior zidovudine PMTCT trial populations includes the higher pretherapy anemia prevalence among Indian study participants. Although 26% of the Indian women had clinically significant anemia before initiating zidovudine PMTCT 28 This Indian study's pregnant HIV-positive population, even with a higher prevalence of pretherapy anemia, did not seem to have more frequent anemia outcomes or associated adverse effects on maternal delivery or newborn birth outcomes compared with other zidovudine PMTCT trial populations.…”

Section: Discussionmentioning

confidence: 98%

“…Between August 16, 2002 and January 30,2006, pregnant women presenting for antenatal care at Sassoon General Hospital, a large urban tertiary care government hospital in Pune, India, were screened for HIV and anemia. HIV-positive women with a serum hemoglobin level .7.5 g/dL and minimum gestational age of 28 weeks were enrolled in the parent trial.…”

Section: Methodsmentioning

confidence: 99%

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Clinically Significant Anemia in HIV-Infected Pregnant Women in India Is Not a Major Barrier to Zidovudine Use for Prevention of Maternal-to-Child Transmission

Sinha

Choi

Nayak

et al. 2007

JAIDS Journal of Acquired Immune Deficiency Syndromes

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A significant proportion of HIV-positive pregnant women in India present for antenatal care with anemia. With concurrent iron and folic acid supplementation, however, zidovudine use is not associated with persistent or worsening anemia or associated adverse outcomes. In Indian community settings, all pregnant HIV-positive women should receive early anemia treatment. Mild anemia should not limit zidovudine use for PMTCT in India.

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Section: Discussionmentioning

confidence: 98%

Section: Methodsmentioning

confidence: 99%

Clinically Significant Anemia in HIV-Infected Pregnant Women in India Is Not a Major Barrier to Zidovudine Use for Prevention of Maternal-to-Child Transmission

Sinha

Choi

Nayak

et al. 2007

JAIDS Journal of Acquired Immune Deficiency Syndromes

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“…It also increased the risk of skin cancer, which also likely resulted from Notch signal inhibition (23). Compared with GSI, AZT is a safe and efficacious antiretroviral drug that is recommended to reduce the risk of HIV vertical transmission in pregnant women according to medical guidelines (24,25). AZT is a widely used drug to prevent or treat HIV/AIDS, is commonly used in pregnancy clinically, and appears to be safe for the infant, suggesting it could be safe for developing organs.…”

Section: Discussionmentioning

confidence: 99%

The telomerase inhibitor AZT enhances differentiation and prevents overgrowth of human pluripotent stem cell–derived neural progenitors

Fang

Shen

et al. 2018

Journal of Biological Chemistry

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Human pluripotent stem cell (hPSC)-based cell-replacement therapy has emerged as a promising approach for addressing numerous neurological diseases. However, hPSC transplantation has the potential to cause human cell overgrowth and cancer, which represents a major obstacle to implementing hPSC-based therapies. Inhibition of the overgrowth of transplanted cells could help reduce the risk for hPSC transplantation-induced tumorigenesis. In this study, we report that the telomerase inhibitor azidothymidine (3'-azido-3'-deoxythymidine; AZT) enhances the differentiation of cortical neurons and significantly suppresses the proliferation of hPSC-derived cortical progenitors. Using human embryonic stem cells and induced pluripotent stem cells in culture, we found that AZT effectively reduces the number of dividing progenitors without inducing cell death. Furthermore, AZT promoted differentiation of cortical progenitors and maturation of cortical neurons. Of note, AZT-pretreated, hPSC-derived neural progenitors exhibited decreased proliferation and increased differentiation into cortical neurons when transplanted into the mouse brain. In summary, our findings indicate that AZT prevents the overgrowth of hPSC-derived neural precursors and enhances the differentiation of cortical neurons in both cell cultures and hPSC-transplanted mouse brain. We propose that our work could inform clinical applications of hPSC-based cell therapy.

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“…Neutropenia was significantly more common with the three-drug regimen than with the other two regimens, a difference that is probably related to the combined suppressive effects of zidovudine and lamivudine on bone marrow production of blood cells. 22–24 …”

Section: Discussionmentioning

confidence: 99%

Three Postpartum Antiretroviral Regimens to Prevent Intrapartum HIV Infection

Nielsen‐Saines

Watts

Veloso³

et al. 2012

N Engl J Med

199

103

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Background The safety and efficacy of adding antiretroviral drugs to standard zidovudine prophylaxis in infants of mothers with human immunodeficiency virus (HIV) infection who did not receive antenatal antiretroviral therapy (ART) because of late identification are unclear. We evaluated three ART regimens in such infants. Methods Within 48 hours after their birth, we randomly assigned formula-fed infants born to women with a peripartum diagnosis of HIV type 1 (HIV-1) infection to one of three regimens: zidovudine for 6 weeks (zidovudine-alone group), zidovudine for 6 weeks plus three doses of nevirapine during the first 8 days of life (two-drug group), or zidovudine for 6 weeks plus nelfinavir and lamivudine for 2 weeks (three-drug group). The primary outcome was HIV-1 infection at 3 months in infants uninfected at birth. Results A total of 1684 infants were enrolled in the Americas and South Africa (566 in the zidovudine-alone group, 562 in the two-drug group, and 556 in the three-drug group). The overall rate of in utero transmission of HIV-1 on the basis of Kaplan–Meier estimates was 5.7% (93 infants), with no significant differences among the groups. Intra-partum transmission occurred in 24 infants in the zidovudine-alone group (4.8%; 95% confidence interval [CI], 3.2 to 7.1), as compared with 11 infants in the two-drug group (2.2%; 95% CI, 1.2 to 3.9; P = 0.046) and 12 in the three-drug group (2.4%; 95% CI, 1.4 to 4.3; P = 0.046). The overall transmission rate was 8.5% (140 infants), with an increased rate in the zidovudine-alone group (P = 0.03 for the comparisons with the two- and three-drug groups). On multivariate analysis, zidovudine monotherapy, a higher maternal viral load, and maternal use of illegal substances were significantly associated with transmission. The rate of neutropenia was significantly increased in the three-drug group (P<0.001 for both comparisons with the other groups). Conclusions In neonates whose mothers did not receive ART during pregnancy, prophylaxis with a two- or three-drug ART regimen is superior to zidovudine alone for the prevention of intrapartum HIV transmission; the two-drug regimen has less toxicity than the three-drug regimen. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development [NICHD] and others; ClinicalTrials.gov number, NCT00099359.)

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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

Cited by 19 publications

References 25 publications

Clinically Significant Anemia in HIV-Infected Pregnant Women in India Is Not a Major Barrier to Zidovudine Use for Prevention of Maternal-to-Child Transmission

Clinically Significant Anemia in HIV-Infected Pregnant Women in India Is Not a Major Barrier to Zidovudine Use for Prevention of Maternal-to-Child Transmission

The telomerase inhibitor AZT enhances differentiation and prevents overgrowth of human pluripotent stem cell–derived neural progenitors

Three Postpartum Antiretroviral Regimens to Prevent Intrapartum HIV Infection

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