Development of Resistance Mutations in Pregnant HIV-Positive (+) Women Following Perinatal Antiretroviral Therapy in Israel

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Hadassah Medical Organization.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00197366
First received: September 14, 2005
Last updated: June 11, 2007
Last verified: September 2005
  Purpose

It has been shown that treatment of HIV-positive women with antiretroviral medication during pregnancy reduces the risk of HIV transmission to the child. However, such treatment could lead to the selection of resistant virus strains in the mother. The object of this study is to check HIV+ pregnant women for resistance mutations in HIV before and after the antiretroviral therapy they receive during pregnancy. HIV-positive newborns will also be tested, to see if a resistant virus strain was transmitted from mother to child.


Condition
HIV Infections

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Official Title: Development of Resistance Mutations in the Human Immunodeficiency Virus (HIV) in Pregnant HIV+ Women Receiving Perinatal Antiretroviral Therapy in Israel

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Estimated Enrollment: 50
Study Start Date: March 2005
Estimated Study Completion Date: December 2007
Detailed Description:

The project will be performed in collaboration with the Israeli National HIV Reference Center Laboratory, which maintains a national bank of HIV-positive blood samples, and with HIV/AIDS treatment centers located throughout Israel.

An initial survey will identify retrospectively those HIV+ women who were given antiretroviral therapy while pregnant and stopped treatment after delivery. The list of HIV+ deliveries over the past five years in each participating hospital will be reviewed, and all HIV-positive women who received antiretroviral treatment during pregnancy will be invited to participate in the study project. Women who are currently pregnant, or become pregnant during the study, will be invited to participate when pregnancy is diagnosed. After obtaining informed consent, two blood samples will be obtained: one before the initiation of perinatal treatment, and the other following delivery. (Due to technical limitations, only samples with viral loads above 1000 cp/ml can be genotyped. It is expected that HIV loads will rise following cessation of antiretroviral treatment, and that almost all samples will be eligible for resistance testing.)

In addition, after obtaining maternal informed consent, samples from newborns infected perinatally with HIV will also be tested for resistance mutations, and these will be compared with the resistance pattern found in the mother.

The samples obtained will be tested for genotypic resistance mutations. The results will be transmitted to the treating physician to assist in choice of antiretroviral therapy for the women and their children, if needed. The data will also be used to establish a national database to evaluate and improve existing protocols for perinatal antiretroviral treatment, and will be used to contribute to international databases of HIV resistance. All resistance data, except that given to the health care provider(s), will be transmitted without additional identifying information.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. HIV-positive women currently pregnant or with a past pregnancy in Israel
  2. Blood/plasma samples available before and/or after perinatal antiretroviral treatment (before or during pregnancy if not treated)
  3. HIV viral load in the samples adequate for resistance testing (approximately 1000 copies/ml)
  4. Informed consent obtained

Exclusion Criteria:

  1. Samples not available or inadequate viral load
  2. Informed consent not obtained
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00197366

Contacts
Contact: Shlomo Maayan, Professor 972-2-6776539 shlomo_m@hadassah.org.il
Contact: Rebekah Karplus, MD 972-50-857-3436 reba_k@netvision.net.il

Locations
Israel
Soroka University Medical Center Recruiting
Beersheva, Israel, 84101
Contact: Klaris Riesenberg, MD    972-8-6403800    klaris@bgumail.bgu.ac.il   
Principal Investigator: Klaris Riesenberg, MD         
Rambam Medical Center Recruiting
Haifa, Israel
Contact: Shimon Pollack, Prof    972-4-854-2222    pollack@rambam.health.gov   
Contact: Einat Kedem, MD    972-4-854-2222    e_kedem@rambam.health.gov   
Principal Investigator: Shimon Pollack, MD         
Sub-Investigator: Einat Kedem, MD         
AIDS Center, Hadassah-Hebrew U Medical Organisation Recruiting
Jerusalem, Israel, 92100
Contact: Shlomo Maayan, Prof    972-2-6776539    shlomo_m@hadassah.org.il   
Contact: Rebekah Karplus, MD    972-50-857-3436    reba_k@netvision.net.il   
Sub-Investigator: Rebekah Karplus, MD         
Sub-Investigator: Dani Engelhard, MD         
Principal Investigator: Shlomo Maayan, MD         
Sub-Investigator: Michelle Hauzi, RN         
Sub-Investigator: Diana Averbuch, MD         
Meir Hospital Sapir Medical Center Recruiting
Kfar Saba, Israel, 95847
Contact: Michal Chowers, MD    972-1-700-70-7065    chowersm@post.tau.ac.il   
Principal Investigator: Michal Chowers, MD         
Kaplan Medical Center Recruiting
Rehovot, Israel, 76100
Contact: Zev Shtaeger, Prof    972-8-944-1211    zev_s@clalit.org.il   
Principal Investigator: Zev Shtaeger, MD         
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Shlomo Maayan, MD Hadassah-Hebrew U Medical Center
Principal Investigator: Zehava Grossman, PhD Central Virology Laboratory Tel HaShomer
Principal Investigator: Rebekah Karplus, MD Hadassah-Hebrew U Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00197366     History of Changes
Other Study ID Numbers: 16-25.02.05-HMO-CTIL
Study First Received: September 14, 2005
Last Updated: June 11, 2007
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
pregnancy
HIV-positive
HIV resistance
HIV

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on July 29, 2014