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Intrauterine Insemination In HIV-Discordant Couples (ARTEMIS)

19 februari 2016 uppdaterad av: Boston Medical Center
This study aims to assess the feasibility of a novel standard of care technique for intrauterine insemination (IUI) in HIV-discordant couples in the United States. This study will involve couples in which the male partner is HIV positive, but the female partner is negative. The investigators will institute a protocol similar to those used presently throughout Europe with good success. To date, no HIV seroconversions have occurred in over 4000 inseminations performed in HIV serodiscordant couples. All male subjects will be on stable HAART, and have undetectable serum viral loads prior to insemination. Semen samples will be subjected to a stringent sperm wash procedure and screened for HIV RNA. Female subjects will be followed post-insemination for seroconversion and pregnancy. Infants will be followed for seroconversion at birth through 4 months of age.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

This study aims to assess the feasibility of a novel standard of care technique for intrauterine insemination (IUI) in HIV-discordant couples in the United States. This study will involve couples in which the male partner is HIV positive, but the female partner is negative.

The investigators will institute a protocol similar to those used presently throughout Europe with good success. To date, no HIV seroconversions have occurred in over 4000 inseminations performed in HIV serodiscordant couples.

All male subjects will be on stable HAART and have undetectable serum viral loads prior to insemination. For semen samples, seminal fluid will be separated from sperm using a density gradient/swim-up separation technique. The purified sperm sample will be washed, and screened for HIV RNA using sensitive real-time RT-PCR. Samples with detectable traces of HIV RNA will not be used for insemination. Samples with no detectable traces of HIV RNA will be used for a standard intrauterine insemination of the female partner.

Female subjects will be followed post-insemination for seroconversion and pregnancy. Infants will be followed for seroconversion at birth through 3 months of age.

The data being collected in this pilot feasibility study will be mostly descriptive, lacking sample size to achieve statistical power for testing. However, the investigators will use case-control analysis to compare couples who achieve pregnancy with those who do not across demographics and markers of HIV disease progression. Additionally, the investigators have developed a 14 item, 5-point Likert scale to assesses the psychosocial impact of reproductive health issues stemming from HIV-discordance in both the female and male participants.

The expected duration for any unique subject couple is 3 to 12 months, depending on pregnancy. It is expected that the interventional portion of this study will continue for up to 2 years, depending on pregnancies.

Studietyp

Interventionell

Inskrivning (Faktisk)

10

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Massachusetts
      • Boston, Massachusetts, Förenta staterna, 02118
        • Boston Medical Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 50 år (Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Couples with HIV discordance with an HIV seronegative female partner and HIV seropositive male partner
  • Men must be HIV positive with an undetectable viral load (<75 copies/ml)
  • Men must be clinical stable on antiretroviral therapy for 6 months
  • Men must have a CD4 count > 250 at screening
  • Men must be between 18-50 years of age
  • Men must have a baseline test sperm preparation demonstrating at least 10 million motile sperm per sample
  • Men must have a letter of medical clearance specific for this procedure from primary care physician stating that subject is in good health and psychologically stable
  • Men must be willing to have constituent follow-up of HIV care throughout study participation
  • Women must have an HIV-1/HIV-2 negative serology at screening
  • Women must be between 18-40 years of age
  • Women must have a body mass index (BMI) less than 30
  • Women must be a non-smoker
  • Women must be ovulatory (as determined by LH tracking)
  • Women must have normal uterine cavity with at least one documented patent fallopian tube (as determined by hysterosalpingogram)
  • Women must have adequate day 3 ovarian reserves: FSH,12 mlU/ml and estradiol<80pg/ml
  • Women must have no evidence of active urogenital infection at screening
  • Women must have a normal PAP smear and GC/Chlamydia at screening
  • Women must have a letter of medical clearance specific to this procedure from subject's primary care physician stating that subject is in good health and psychological stable.

Exclusion Criteria:

  • Subjects with untreated sexually transmitted diseases (syphilis, GC, CT)
  • Men with detectable viral load (>75) at screening
  • Subjects with any condition (including, but not limited to alcohol and drug use), which, in the opinion of the investigator, could compromise the subject's safety or adherence to the protocol
  • Subjects with any uncontrollable medical or psychiatric condition that,in the opinion of the investigator, cannot be adequately stabilized and could be considered a contraindication to participation

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Pregnancy
Tidsram: Sixteen days after IUI
A serum pregnancy test will be performed 16 days after IUI if menses is missed.
Sixteen days after IUI

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Post-IUI HIV Infection of Female Subject
Tidsram: Four weeks after IUI
The female subject will be tested for HIV by branch-DNA (b-DNA) test four weeks after each insemination.
Four weeks after IUI
Female Subject HIV-1/HIV-2 Serology
Tidsram: Three, six, nine (pregnant only) and twelve months after insemination
If the female subject does not become pregnant, she will be tested for HIV-1/HIV-2 serology at 3 months, 6 months and 12 months after the insemination. If repeat inseminations are performed, the above-stated timeline will be followed based on the last insemination performed. If the female subject does become pregnant, she will be tested for HIV-1/HIV-2 serology at 3 months, 6 months and 9 months after the insemination, and again at 3 months postpartum.
Three, six, nine (pregnant only) and twelve months after insemination
Infant HIV-1/HIV-2 Serology
Tidsram: Three months of age
For a successful birth, the infant will undergo an HIV-1/HIV-2 serology test at three months of age.
Three months of age

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Boston Medical Center

Utredare

  • Huvudutredare: Margaret M Sullivan, MD, Boston Medical Center

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 september 2009

Primärt slutförande (Faktisk)

1 september 2012

Avslutad studie (Faktisk)

1 oktober 2013

Studieregistreringsdatum

Först inskickad

28 juli 2010

Först inskickad som uppfyllde QC-kriterierna

30 juli 2010

Första postat (Uppskatta)

2 augusti 2010

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

22 februari 2016

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

19 februari 2016

Senast verifierad

1 januari 2012

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • ARTEMIS

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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