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

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. Identifier: NCT00197366
Recruitment Status : Terminated (Difficulties in data collection)
First Posted : September 20, 2005
Last Update Posted : November 28, 2017
Information provided by:
Hadassah Medical Organization

Brief Summary:
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 or disease
HIV Infections

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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Time Perspective: Retrospective
Official Title: Development of Resistance Mutations in the Human Immunodeficiency Virus (HIV) in Pregnant HIV+ Women Receiving Perinatal Antiretroviral Therapy in Israel
Study Start Date : March 2005
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00197366

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Soroka University Medical Center
Beersheva, Israel, 84101
Rambam Medical Center
Haifa, Israel
AIDS Center, Hadassah-Hebrew U Medical Organisation
Jerusalem, Israel, 92100
Meir Hospital Sapir Medical Center
Kfar Saba, Israel, 95847
Kaplan Medical Center
Rehovot, Israel, 76100
Sponsors and Collaborators
Hadassah Medical Organization
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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

Layout table for additonal information Identifier: NCT00197366     History of Changes
Other Study ID Numbers: 16-25.02.05-HMO-CTIL
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: November 28, 2017
Last Verified: September 2005

Keywords provided by Hadassah Medical Organization:
HIV resistance

Additional relevant MeSH terms:
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HIV Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Immune System Diseases
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents