HIV InfectionsNCT00197366
Development of Resistance Mutations in Pregnant HIV-positive (+) Women Following Perinatal Antiretroviral Therapy in Israel
An observational study of HIV Infections, run by Hadassah Medical Organization at 5 sites in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV Infections
- How many people
- 50 participants
- Where
- 5 sitesIsrael
- Study dates
- Mar 2005to Dec 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Samples not available or inadequate viral load
- Informed consent not obtained
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Israel5 sites
Soroka University Medical Center
Beersheva, 84101
Rambam Medical Center
Haifa
AIDS Center, Hadassah-Hebrew U Medical Organisation
Jerusalem, 92100
Meir Hospital Sapir Medical Center
Kfar Saba, 95847
Kaplan Medical Center
Rehovot, 76100
About this study
Official title: Development of Resistance Mutations in the Human Immunodeficiency Virus (HIV) in Pregnant HIV+ Women Receiving Perinatal Antiretroviral Therapy in Israel
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.
Read the 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.
- Conditions
- HIV Infections
- Keywords
- pregnancy, HIV-positive, HIV resistance, HIV
- Medical subject headings
- HIV Infections, HIV Seropositivity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startMar 2005
- Study completionDec 2007
Why it stopped: Difficulties in data collection
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Shlomo Maayan, MD, Principal investigator, Hadassah-Hebrew U Medical CenterZehava Grossman, PhD, Principal investigator, Central Virology Laboratory Tel HaShomerRebekah Karplus, MD, Principal investigator, Hadassah-Hebrew U Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00197366
- Sponsor's protocol ID
- 16-25.02.05-HMO-CTIL
- Status last verified
- Sep 2005
- First submitted
- 14 Sep 2005
- Last updated
- 28 Nov 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Resistance Mutations in the Human Immunodeficiency Virus (HIV) in Pregnant HIV+ Women Receiving Perinatal Antiretroviral Therapy in Israel
- ClinicalTrials.gov ID
- NCT00197366
- Acronym / sponsor ID
- 16-25.02.05-HMO-CTIL
- Conditions
- HIV Infections
- Keywords
- pregnancy, HIV-positive, HIV resistance, HIV
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Difficulties in data collection
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Mar 2005
- Study completion
- Dec 2007
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Samples not available or inadequate viral load
- Informed consent not obtained
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Difficulties in data collection). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shlomo Maayan, MD principal investigator
Hadassah-Hebrew U Medical Center
Zehava Grossman, PhD principal investigator
Central Virology Laboratory Tel HaShomer
Rebekah Karplus, MD principal investigator
Hadassah-Hebrew U Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by Hadassah Medical Organization at 5 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulties in data collection). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2017.