Intrauterine Insemination In HIV-Discordant Couples (ARTEMIS)

February 19, 2016 updated by: 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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy
Time Frame: Sixteen days after IUI
A serum pregnancy test will be performed 16 days after IUI if menses is missed.
Sixteen days after IUI

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Four weeks after IUI
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.
Three, six, nine (pregnant only) and twelve months after insemination
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.
Three months of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Medical Center

Investigators

  • Principal Investigator: Margaret M Sullivan, MD, Boston Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

July 28, 2010

First Submitted That Met QC Criteria

July 30, 2010

First Posted (Estimate)

August 2, 2010

Study Record Updates

Last Update Posted (Estimate)

February 22, 2016

Last Update Submitted That Met QC Criteria

February 19, 2016

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARTEMIS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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