CD4-guided structured antiretroviral treatment interruption strategy in HIV-infected adults in west Africa (Trivacan ANRS 1269 trial): a randomised trial

Danel, Christine; Moh, Raoul; Minga, Albert; Anzian, Amani; Ba-Gomis, Olivier; Kanga, Constance; Nzunetu, Gustave; Gabillard, Delphine; Raffi, François; Sorho, Souleymane; Chaix, Marie‐Laure; Eholié, Serge; Menan, Hervé; Sauvageot, Delphine; Bissagnené, E.; Salamon, Roger; Anglaret, Xavier

doi:10.1016/s0140-6736(06)68887-9

Cited by 203 publications

(165 citation statements)

References 30 publications

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“…In larger randomized control studies of HIV-1-infected patients that excluded pregnant women (the SMART and the Trivacan studies), HAART interruption was found to lead to higher rates of morbidity and mortality. 9,15 A randomized study, the HAART Standard Version of the Promoting Maternal and Infant Survival Everywhere (PROMISE) Study, is planned and will assess maternal health outcomes among women who initiate HAART during pregnancy for PMTCT and not for their own health. 11 Results of this interventional trial are not expected for several years.…”

Section: Discussionmentioning

confidence: 99%

Postpartum Discontinuation of Antiretroviral Therapy and Risk of Maternal AIDS-Defining Events, Non-AIDS–Defining Events, and Mortality Among a Cohort of HIV-1–Infected Women in the United States

Melekhin

Shepherd

Jenkins

et al. 2010

AIDS Patient Care and STDs

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This retrospective cohort study of HIV-infected women receiving highly active antiretroviral therapy (HAART) while pregnant assessed the effect of postpartum HAART discontinuation on maternal AIDS-defining events (ADEs), non-AIDS-defining events (non-ADEs), and death 1997-2008 in Nashville, Tennessee. Cox proportional hazards models compared rates of ADE or all-cause death and non-ADE or all-cause death, and competing risks analyses compared rates of ADE or ADE-related death and non-ADE or non-ADE-related death across the groups. There were two groups: women who stopped HAART postpartum (discontinuation, n ¼ 54) and women who continued HAART postpartum (continuation, n ¼ 69). Fifty percent were African American, 40% had prior non-HAART antiretroviral therapy (ART) use, and 38% had a history of illicit drug use. Median age was 27.5 years, baseline CD4(%) was 532 (34%) and CD4 nadir was 332 cells=mm 3 , baseline and peak HIV-1 RNA were 2.6 and 4.32 log 10 copies per milliliter, respectively. Women in the continuation group were older, had lower baseline CD4, CD4%, and CD4 nadir, and had higher peak HIV-1 RNA. In multivariable proportional hazards models, the hazard ratios [95% confidence interval (CI)] of ADE or all-cause death and non-ADE or all-cause death were lower in the continuation group, but not statistically significantly: 0.50 (0.12, 2.12; p ¼ 0.35) and 0.69 (0.24, 1.95; p ¼ 0.48), respectively. The results were similar in competing risks analyses. Despite having characteristics associated with worse prognosis, women who continued HAART postpartum had lower hazard ratio point estimates for ADEs or death and non-ADEs or death than women who discontinued HAART. Larger studies with longer follow-up are indicated to assess this association.

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Section: Discussionmentioning

confidence: 99%

Postpartum Discontinuation of Antiretroviral Therapy and Risk of Maternal AIDS-Defining Events, Non-AIDS–Defining Events, and Mortality Among a Cohort of HIV-1–Infected Women in the United States

Melekhin

Shepherd

Jenkins

et al. 2010

AIDS Patient Care and STDs

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show abstract

“…What information there is comes from early RCTs with zidovudine monotherapy [143] with or without HIV immunoglobulin [144] and from observational studies with their inherent weaknesses [145][146][147][148]. Nevertheless, concerns have been raised regarding the discontinuation of ARVs postpartum in light of results from CD4-guided interruption studies (SMART [149] and TRIVICAN [150] in particular) although interruption of ART given for PMTCT after delivery is not completely analogous. In both these studies, which were halted prematurely because of the significantly worse outcome in the CD4-guided interruption arm, lower CD4 cell count thresholds for resumption of therapy were used than would be currently based on clinical treatment guidelines.…”

Section: Grading: 1bmentioning

confidence: 99%

11.0 References

2012

HIV Medicine

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“…The CD4-guided arm of TRIVACAN reported an increased risk for invasive bacterial infections. The STI arm was declared noninferior to the continuous therapy arm [16].…”

Section: Cd4-guided Structured Treatment Interruptions Trials In Chromentioning

confidence: 99%

Structured treatment interruptions in chronic HIV management: where next?

Pai

Klein

2006

Expert Review of Anti-infective Therapy

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CD4-guided structured antiretroviral treatment interruption strategy in HIV-infected adults in west Africa (Trivacan ANRS 1269 trial): a randomised trial

Cited by 203 publications

References 30 publications

Postpartum Discontinuation of Antiretroviral Therapy and Risk of Maternal AIDS-Defining Events, Non-AIDS–Defining Events, and Mortality Among a Cohort of HIV-1–Infected Women in the United States

Postpartum Discontinuation of Antiretroviral Therapy and Risk of Maternal AIDS-Defining Events, Non-AIDS–Defining Events, and Mortality Among a Cohort of HIV-1–Infected Women in the United States

11.0 References

Structured treatment interruptions in chronic HIV management: where next?

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