HIV InfectionNCT00026676
Correlation of HIV Levels With Clinical and Immunologic Outcome in Children Treated With Didanosine
An observational study of HIV Infection, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Recent studies have shown that patients receiving state-of-the-art treatment for HIV infection (highly active antiretroviral therapy, or HAART) show discordant responses to therapy-that is, they improve both clinically and immunologically (increased CD4 immune cell counts), but their levels of HIV in the blood do not… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV Infection
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- May 2000to Apr 2003
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Prior enrollment on NCI protocol 88-C-0219, a phase I/II study of 2',3'- dideoxyinosine (ddI) in children with human immunodeficiency virus infection.
- Informed consent for participation in 88-C-0219 clinical trial.
- Adequate available clinical and immunologic data and banked blood specimen components obtained during implementation of the protocol.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
About this study
Official title: Retrospective Analysis of HIV-1 RNA Levels in Pediatric HIV-Infected Patients Treated With Didanosine
Recent studies have shown that patients receiving state-of-the-art treatment for HIV infection (highly active antiretroviral therapy, or HAART) show discordant responses to therapy-that is, they improve both clinically and immunologically (increased CD4 immune cell counts), but their levels of HIV in the blood do not drop. This study will examine blood samples taken from HIV-infected children treated with 2',3'-dideoxyinosine (didanosine, or ddI) in an earlier NCI study to determine if these patients had similar discordant responses to therapy. If so, the study will also examine how these factors may be predictive of disease progression and survival.
Investigators will measure HIV levels in blood specimens from children previously enrolled in NCI protocol 88-C-0129. The measurements will be done in specimens drawn before initiation of treatment with ddI and at various times during the course of treatment. The viral responses to therapy will then be correlated with short- and long-term clinical and immunologic outcomes.
Read more
In addition, researchers will examine these patients' blood samples for additional factors recently discovered to potentially influence disease progression. They include selenium levels and certain genetic factors.
A better understanding of discordant responses to therapy will help physicians determine the best treatment option in situations where therapy results do not show uniform benefit.
This protocol involves the scientific examination of laboratory specimens only and is not a clinical study open to patient enrollment.
Read the detailed description
This study will examine clinical and immunologic data and HIV-1 RNA levels in banked serum specimens from HIV-infected pediatric patients previously enrolled on NCI protocol 88-C-0219, a phase I/II study of 2', 3'-dideoxyinosine (ddI). In the original study serum p24 antigen was used as the direct measurement of viral quantitation. Advances in understanding of HIV pathophysiology have demonstrated that HIV-1 RNA level as measured by quantitative RNA PCR is a far superior molecular tool for assessing viral replication and burden in vivo. Analysis of clinical, HIV-1 RNA and CD4 responses will be performed to identify patients with discordant surrogate marker responses to therapy, defined as: improvement in immunologic parameters in the setting of virologic non-response or failure. Correlation will then be made with short and long term clinical outcomes.
Following the initial analysis to identify patients with discordant responses, selenium levels, viral genotypic and phenotypic profiles of resistance to ddI, and in vitro viral fitness will be examined. These biologic parameters have recently been determined to potentially play an important role in clinical, immunologic and virologic HIV-related outcomes. Parameters will be examined in subsets of patients with the following surrogate marker response profiles: a.) immunologic and virologic responders; b.) immunologic and virologic non-responders; and c.) discordant immunologic and virologic responders. Specimens from the ddI monotherapy study were chosen for this analysis because a substantial body of clinical and immunologic data is available on patients up to 7 years.
- Conditions
- HIV Infection
- Keywords
- Surrogate Markers, Genotypic Resistance, Phenotypic Resistance, Selenium
- 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 posted15 Nov 2001 (estimated)
- Study startMay 2000
- Study completionApr 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Enrolment
- 82 participants
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00026676
- Sponsor's protocol ID
- 000130
- Other IDs
- 00-C-0130
- Status last verified
- Apr 2003
- First submitted
- 14 Nov 2001
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Hogg RS, O'Shaughnessy MV, Gataric N, Yip B, Craib K, Schechter MT, Montaner JS. Decline in deaths from AIDS due to new antiretrovirals. Lancet. 1997 May 3;349(9061):1294. doi: 10.1016/S0140-6736(05)62505-6. No abstract available.
PubMed 9142067Egger M, Hirschel B, Francioli P, Sudre P, Wirz M, Flepp M, Rickenbach M, Malinverni R, Vernazza P, Battegay M. Impact of new antiretroviral combination therapies in HIV infected patients in Switzerland: prospective multicentre study. Swiss HIV Cohort Study. BMJ. 1997 Nov 8;315(7117):1194-9. doi: 10.1136/bmj.315.7117.1194.
PubMed 9393221Palella FJ Jr, Delaney KM, Moorman AC, Loveless MO, Fuhrer J, Satten GA, Aschman DJ, Holmberg SD. Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. HIV Outpatient Study Investigators. N Engl J Med. 1998 Mar 26;338(13):853-60. doi: 10.1056/NEJM199803263381301.
PubMed 9516219
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of HIV-1 RNA Levels in Pediatric HIV-Infected Patients Treated With Didanosine
- ClinicalTrials.gov ID
- NCT00026676
- Acronym / sponsor ID
- 000130
- Conditions
- HIV Infection
- Keywords
- Surrogate Markers, Genotypic Resistance, Phenotypic Resistance, Selenium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- May 2000
- Study completion
- Apr 2003
- First posted
- 15 Nov 2001 (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.
Recent studies have shown that patients receiving state-of-the-art treatment for HIV infection (highly active antiretroviral therapy, or HAART) show discordant responses to therapy-that is, they improve both clinically and immunologically (increased CD4 immune cell counts), but their levels of HIV in the blood do not drop. This study will examine blood samples taken from HIV-infected children treated with 2',3'-dideoxyinosine (didanosine, or ddI) in an earlier NCI study to determine if these patients had similar discordant responses to therapy. If so, the study will also examine how these factors may be predictive of disease progression and survival.
Investigators will measure HIV levels in blood specimens from children previously enrolled in NCI protocol 88-C-0129. The measurements will be done in specimens drawn before initiation of treatment with ddI and at various times during the course of treatment. The viral responses to therapy will then be correlated with short- and long-term clinical and immunologic outcomes.
In addition, researchers will examine these patients' blood samples for additional factors recently discovered to potentially influence disease progression. They include selenium levels and certain genetic factors.
A better understanding of discordant responses to therapy will help physicians determine the best treatment option in situations where therapy results do not show uniform benefit.
This protocol involves the scientific examination of laboratory specimens only and is not a clinical study open to patient enrollment.
Detailed description
This study will examine clinical and immunologic data and HIV-1 RNA levels in banked serum specimens from HIV-infected pediatric patients previously enrolled on NCI protocol 88-C-0219, a phase I/II study of 2', 3'-dideoxyinosine (ddI). In the original study serum p24 antigen was used as the direct measurement of viral quantitation. Advances in understanding of HIV pathophysiology have demonstrated that HIV-1 RNA level as measured by quantitative RNA PCR is a far superior molecular tool for assessing viral replication and burden in vivo. Analysis of clinical, HIV-1 RNA and CD4 responses will be performed to identify patients with discordant surrogate marker responses to therapy, defined as: improvement in immunologic parameters in the setting of virologic non-response or failure. Correlation will then be made with short and long term clinical outcomes.
Following the initial analysis to identify patients with discordant responses, selenium levels, viral genotypic and phenotypic profiles of resistance to ddI, and in vitro viral fitness will be examined. These biologic parameters have recently been determined to potentially play an important role in clinical, immunologic and virologic HIV-related outcomes. Parameters will be examined in subsets of patients with the following surrogate marker response profiles: a.) immunologic and virologic responders; b.) immunologic and virologic non-responders; and c.) discordant immunologic and virologic responders. Specimens from the ddI monotherapy study were chosen for this analysis because a substantial body of clinical and immunologic data is available on patients up to 7 years.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Prior enrollment on NCI protocol 88-C-0219, a phase I/II study of 2',3'- dideoxyinosine (ddI) in children with human immunodeficiency virus infection.
- Informed consent for participation in 88-C-0219 clinical trial.
- Adequate available clinical and immunologic data and banked blood specimen components obtained during implementation of the protocol.
Key exclusion criteria (0 listed)
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 4 Mar 2008.
- Background: PubMed 9142067Hogg RS, O'Shaughnessy MV, Gataric N, Yip B, Craib K, Schechter MT, Montaner JS. Decline in deaths from AIDS due to new antiretrovirals. Lancet. 1997 May 3;349(9061):1294. doi: 10.1016/S0140-6736(05)62505-6. No abstract available.
- Background: PubMed 9393221Egger M, Hirschel B, Francioli P, Sudre P, Wirz M, Flepp M, Rickenbach M, Malinverni R, Vernazza P, Battegay M. Impact of new antiretroviral combination therapies in HIV infected patients in Switzerland: prospective multicentre study. Swiss HIV Cohort Study. BMJ. 1997 Nov 8;315(7117):1194-9. doi: 10.1136/bmj.315.7117.1194.
- Background: PubMed 9516219Palella FJ Jr, Delaney KM, Moorman AC, Loveless MO, Fuhrer J, Satten GA, Aschman DJ, Holmberg SD. Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. HIV Outpatient Study Investigators. N Engl J Med. 1998 Mar 26;338(13):853-60. doi: 10.1056/NEJM199803263381301.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 National Cancer Institute (NCI) at 1 site in United States.
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 3 inclusion and 0 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 4 Mar 2008. 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 United States. 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 NCT00026676, which also lists 3 linked publications.
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 4 Mar 2008.