HIV InfectionNCT00159068
Analysis of Genetic Factors Which May Influence the Course of HIV Infection
An observational study of HIV Infection, run by Deborah Rund at 1 site in Israel.
Trial summary
Patients with HIV an have a variable course of their infection. We are trying to identify factors which worsen or ameliorate the course of the disease. Such factors may be related to metabolism (breakdown) of drugs or to iron handling by the body. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2004to Apr 2011
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with HIV attending the HIV clinic at Hadassah colden globes.
Who may be able to join
- diagnosis of HIV
Who cannot join
- under 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Genetic Influences on the Course and Response to Treatment of HIV: Contribution of Polymorphisms in Drug Metabolism and Disposition Genes and Haptoglobin Polymorphisms
Patients with HIV an have a variable course of their infection. We are trying to identify factors which worsen or ameliorate the course of the disease. Such factors may be related to metabolism (breakdown) of drugs or to iron handling by the body.
Read the detailed description
Patients with HIV can have a variable course and the disease may be influenced by polymorphisms in drug metabolism and disposition genes such as MDR1 and CYP3A4. In addition, reports have linked changes in the course of the disease with iron status, with high iron being detrimental. We will study polymorphisms in these genes and correlate with clinical course in HIV patients and also with phenotype of drug resistance and disease parameters (such as CD4 counts and opportunistic infections).
- Conditions
- HIV Infection
- Medical subject headings
- HIV Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startFeb 2004
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- 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
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deborah Rund
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Deborah Rund, Hadassah Medical Organization
- Investigators
- Deborah Rund, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00159068
- Sponsor's protocol ID
- 391200-HMO-CTIL
- Status last verified
- Aug 2017
- First submitted
- 9 Sep 2005
- Last updated
- 10 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Tang J, Kaslow RA. The impact of host genetics on HIV infection and disease progression in the era of highly active antiretroviral therapy. AIDS. 2003;17 Suppl 4:S51-60. doi: 10.1097/00002030-200317004-00006. No abstract available.
PubMed 15080180
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Influences on the Course and Response to Treatment of HIV: Contribution of Polymorphisms in Drug Metabolism and Disposition Genes and Haptoglobin Polymorphisms
- ClinicalTrials.gov ID
- NCT00159068
- Acronym / sponsor ID
- 391200-HMO-CTIL
- Conditions
- HIV Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Deborah RundUniversity, hospital or other
- Study start
- Feb 2004
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 12 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.
Patients with HIV an have a variable course of their infection. We are trying to identify factors which worsen or ameliorate the course of the disease. Such factors may be related to metabolism (breakdown) of drugs or to iron handling by the body.
Detailed description
Patients with HIV can have a variable course and the disease may be influenced by polymorphisms in drug metabolism and disposition genes such as MDR1 and CYP3A4. In addition, reports have linked changes in the course of the disease with iron status, with high iron being detrimental. We will study polymorphisms in these genes and correlate with clinical course in HIV patients and also with phenotype of drug resistance and disease parameters (such as CD4 counts and opportunistic infections).
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with HIV attending the HIV clinic at Hadassah colden globes.
Key inclusion criteria (1 listed)
- diagnosis of HIV
Key exclusion criteria (1 listed)
- under 18 years of age
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2017.
- Background: PubMed 15080180Tang J, Kaslow RA. The impact of host genetics on HIV infection and disease progression in the era of highly active antiretroviral therapy. AIDS. 2003;17 Suppl 4:S51-60. doi: 10.1097/00002030-200317004-00006. No abstract available.
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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.
Deborah Rund, MD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infection, run by Deborah Rund at 1 site 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 10 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
On the ClinicalTrials.gov record for NCT00159068, which also lists 1 linked publication.
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 10 Aug 2017.