Development of Resistance Mutations in Pregnant HIV-Positive (+) Women Following Perinatal Antiretroviral Therapy in Israel
Recruitment status was Recruiting
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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 |
| Estimated Enrollment: | 50 |
| Study Start Date: | March 2005 |
| Estimated Study Completion Date: | December 2007 |
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 |
Inclusion Criteria:
- HIV-positive women currently pregnant or with a past pregnancy in Israel
- Blood/plasma samples available before and/or after perinatal antiretroviral treatment (before or during pregnancy if not treated)
- HIV viral load in the samples adequate for resistance testing (approximately 1000 copies/ml)
- Informed consent obtained
Exclusion Criteria:
- Samples not available or inadequate viral load
- Informed consent not obtained
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00197366
| 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 |
| 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 | |
| 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 |
ClinicalTrials.gov processed this record on March 02, 2015