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Open Label Study of NVP+CBV Treatment in Women Who Have Received sdNVP for the pMTCT of HIV

13. november 2013 opdateret af: Boehringer Ingelheim

An Open-Label Study of Nevirapine Plus Combivir® (ZDV+3TC) Treatment in Women Who Have Previously Received a Nevirapine Regimen for the Prevention of Mother to Child Transmission (pMTCT) of HIV-1.

To determine the response to treatment with NVP, ZDV and 3TC in HIV positive women, who previously received NVP for the prevention of mother to child transmission.

Studieoversigt

Status

Afsluttet

Betingelser

Erhvervet immundefektsyndrom

Intervention / Behandling

Detaljeret beskrivelse

An open-label, single arm, multicentre study to determine the virologic and immunologic responsiveness of women, who previously received a regimen of nevirapine for the prevention of MTCT, to a regimen of nevirapine and ZDV+3TC treatment. As well as to evaluate the proportion of patients who fail this treatment at 24 and 48 weeks, and to evaluate the resistance profile of HIV isolates from patients who fail nevirapine and ZDV+3TC treatment.

Study Hypothesis:

When a drug leading to selection of a resistant viral population is withdrawn the original wildtype virus, over time, becomes the predominant virus again. However, low frequency (below level of detection) of drug resistant viral sub-populations may be retained which could mean that the drug resistant variant might reappear rapidly should the same drug be reintroduced as part of combination therapy at a later stage.Therefore this study is proposed to evaluate whether there is an impact of single dose nevirapine for the prevention of MTCT on the subsequent response to a standard HAART regimen that contains nevirapine.

Comparison(s):

trial 1100.1090

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

Fase

Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Sydafrika
- - Capetown, Sydafrika, 7925
    - Boehringer Ingelheim Investigational Site
  - Parow, Sydafrika, 7505
    - Boehringer Ingelheim Investigational Site
  - Soweto, Sydafrika, 2013
    - Boehringer Ingelheim Investigational Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

19 år til 45 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

INCLUSION CRITERIA

HIV-1-infected non-pregnant women who received a nevirapine regimen, for the prevention of mother to child transmission, at least 12 months previously.
Women of child-bearing potential must have a negative urine pregnancy test at the screening visit and ensure double barrier methods of contraception, which by definition will in all cases include the use of condoms, throughout the study period.
CD4 cell count < 350 cells/mm3 and viral load HIV-1 RNA > 20,000 c/mL or any symptomatic individual (WHO stage 3) or the presence of any AIDS defining criteria.
Documented HIV-1 positive status by a licensed HIV-1 ELISA test.

EXCLUSION CRITERIA

Women who are pregnant or breastfeeding.
Women with prior exposure to antiretroviral therapy, other than a nevirapine regimen for the prevention of mother to child transmission at least 12 months previously.
Subjects who in the investigator's opinion are unlikely to complete the 48 week study period or unlikely to comply with the dosing schedule and protocol evaluations.
Patients with a Karnofsky performance status score < 70.
Subjects who fail to meet the HIV treatment criteria (CD4 and viral load) indicated above.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: Ikke-randomiseret
Interventionel model: Enkelt gruppeopgave
Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
The proportion of patients who fail to suppress viral load to 400c/mL or maintain a viral load 400 c/mL at 24 and 48 weeks. The mean change in HIV RNA measurement by 24 weeks.

Sekundære resultatmål

Resultatmål
What type of resistance that develops Immunologic response to treatment Treatment safety Time to treatment and/or virologic failure 5.How many achieve viral loads<50c/mL

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Boehringer Ingelheim

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Related Info

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2003

Primær færdiggørelse (Faktiske)

1. juli 2006

Studieafslutning