Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 21 of 181 for:    DCLRE1C

Intrauterine Insemination In HIV-Discordant Couples (ARTEMIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01173276
Recruitment Status : Terminated (The field has changed, and we have decided to develop a PrEP program.)
First Posted : August 2, 2010
Last Update Posted : February 22, 2016
Sponsor:
Information provided by (Responsible Party):
Boston Medical Center

Tracking Information
First Submitted Date  ICMJE July 28, 2010
First Posted Date  ICMJE August 2, 2010
Last Update Posted Date February 22, 2016
Study Start Date  ICMJE September 2009
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 30, 2010)
Pregnancy [ Time Frame: Sixteen days after IUI ]
A serum pregnancy test will be performed 16 days after IUI if menses is missed.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01173276 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2010)
  • Post-IUI HIV Infection of Female Subject [ Time Frame: Four weeks after IUI ]
    The female subject will be tested for HIV by branch-DNA (b-DNA) test four weeks after each insemination.
  • Female Subject HIV-1/HIV-2 Serology [ Time Frame: 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.
  • Infant HIV-1/HIV-2 Serology [ Time Frame: Three months of age ]
    For a successful birth, the infant will undergo an HIV-1/HIV-2 serology test at three months of age.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intrauterine Insemination In HIV-Discordant Couples
Official Title  ICMJE Intrauterine Insemination In HIV-Discordant Couples
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • HIV-1
  • Fertility
  • Infertility
Intervention  ICMJE Other: Sperm Washing with Intrauterine Insemination (IUI)
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.
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 21, 2012)
10
Original Estimated Enrollment  ICMJE
 (submitted: July 30, 2010)
50
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01173276
Other Study ID Numbers  ICMJE ARTEMIS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boston Medical Center
Study Sponsor  ICMJE Boston Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Margaret M Sullivan, MD Boston Medical Center
PRS Account Boston Medical Center
Verification Date January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP