HIV InfectionNCT00001826
Observation of HIV-Infected Children Receiving Protease Inhibitor and Reverse Transcriptase Inhibitor
An observational study of HIV Infection, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This study will continue to follow children who participated in an earlier National Cancer Institute trial of HIV treatment with a protease inhibitor. Children in this study will receive a combination of at least three drugs that include at least one protease inhibitor and one reverse transcriptase inhibitor. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV Infection
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 1999to May 2006
- 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
- Age greater than 1 year and less than 21 years.
- Diagnosis of HIV-1 infection as defined by the Centers for Disease Control (CDC).
- Currently on at least a three drug combination that includes a protease inhibitor (PI) and reverse transcriptase inhibitor (RTI) therapy for at least 6 months.
- Patient must have received initial protease inhibitor treatment in studies in the HIV and AIDS Malignancy Branch but need not be enrolled on another NIH study to be eligible for this protocol.
- Age-adjusted CD4+ T lymphocytes greater than 200 cells/ml.
- Measurements of CD4+45RA+ and CD4+45RO+ T lymphocytes taken within 9 weeks of the time of initiation of protease-inhibitor therapy.
- Availability of a parent or guardian to provide informed consent.
Who cannot join
- Critically ill or clinically unstable child.
- Patients receiving treatment for an infection that requires prolonged treatment must have been stable on therapy for at least 14 days prior to study entry.
- Administration of chemotherapeutic agents or use of immunomodulating agents such as high dose corticosteroids, interferons, pentoxifylline, G-CSF/GM-CSF, erythropoietin, growth hormone and other growth factors within one month of enrollment. However, patients on anti-inflammatory drugs or stable doses of immunoglobulins (including hyperimmune immunoglobulin) will be eligible unless the latter are directed at a T-cell specific antigen.
- Sexually active post-menarchal female unwilling to use a barrier method of contraception or unwilling to remain sexually abstinent.
- Patients who, in the opinion of the Protocol Chairperson or Principal Investigator:
- may not be likely to benefit from this study,
- may be put at undue risk by participation in this study,
- are unlikely to comply with the study requirements.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
About this study
Official title: A Long-Term Observational Study of Immunologic Reconstitution in HIV-1 Infected Children Who Are Receiving Combination Protease Inhibitor and Reverse Transcriptase Inhibitors
This study will continue to follow children who participated in an earlier National Cancer Institute trial of HIV treatment with a protease inhibitor. Children in this study will receive a combination of at least three drugs that include at least one protease inhibitor and one reverse transcriptase inhibitor.
The study will examine to what extent these drugs can restore immune function in HIV-infected children and over what length of time. It will look at changes in the amounts of virus and the specific types of immune cells in the body over the 96-week trial period. It will also examine patients' immune system response to influenza and tetanus vaccinations.
The children will either continue to receive the anti-HIV drugs they have been taking, or their medicines will be changed to a different combination of protease inhibitor and reverse transcriptase inhibitor. Before and during the study, patients will undergo various tests, including a physical examination, blood tests and chest X ray, immune response tests, CT scan, eye examination, electrocardiogram and echocardiogram. A procedure called apheresis may be done to collect white blood cells. In this procedure, whole blood is drawn similar to donating blood, the white cells are separated out by a machine, and the red cells are returned to the body.
Read the detailed description
This study will evaluate the extent of immunoreconstitution in children receiving combination antiretroviral therapy that includes a protease inhibitor and reverse transcriptase inhibitors. The children who will be evaluated and followed in this study are those who have previously been studied on other protease inhibitor-containing anti-HIV protocols within the HIV and AIDS Malignancy Branch. This study will provide a mechanism to assess the long-term immunologic changes of potent combination therapy in this unique population and to relate this to the virologic changes. A total of 50 HIV-1 infected children will be studied. The children enrolled in this protocol will either continue their current combination of protease inhibitor and reverse transcriptase therapy or, if deemed clinically appropriate, will be changed to a new, best available combination of protease inhibitor and reverse transcriptase inhibitors. Long-term immunoreconstitution, defined as the repopulation of naive CD4+T lymphocytes, will be studied by determining the presence and extent of production of new naive (thymic derived) CD4+T cells and by the ability of patients to mount new helper T cell responses after immunization with influenza and tetanus toxoid. Expansion of T cell receptor will also be explored in subsets of enrolled patients. In addition, unforeseen toxicities attributable to the use of combination antiretroviral therapy have been recognized and described in adult patients. This study will evaluate abnormalities in lipid and glucose metabolism, changes in the distribution of body fat, and surrogate markers of cardiovascular disease risk in this cohort of pediatric patients.
- Conditions
- HIV Infection
- Keywords
- CD-4-Naive T Cells, CD-4-Memory T Cells, Antiviral Activity, VB Repertoire, Immunizations, HIV, Treatment Experienced
- 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 posted4 Nov 1999 (estimated)
- Study startJul 1999
- Study completionMay 2006
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
- 50 participants
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001826
- Sponsor's protocol ID
- 990134
- Other IDs
- 99-C-0134
- Status last verified
- May 2006
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Clerici M, Shearer GM. Correlates of protection in HIV infection and the progression of HIV infection to AIDS. Immunol Lett. 1996 Jun;51(1-2):69-73. doi: 10.1016/0165-2478(96)02557-6.
PubMed 8811347Ho DD. Toward HIV eradication or remission: the tasks ahead. Science. 1998 Jun 19;280(5371):1866-7. doi: 10.1126/science.280.5371.1866. No abstract available.
PubMed 9669944Chun TW, Carruth L, Finzi D, Shen X, DiGiuseppe JA, Taylor H, Hermankova M, Chadwick K, Margolick J, Quinn TC, Kuo YH, Brookmeyer R, Zeiger MA, Barditch-Crovo P, Siliciano RF. Quantification of latent tissue reservoirs and total body viral load in HIV-1 infection. Nature. 1997 May 8;387(6629):183-8. doi: 10.1038/387183a0.
PubMed 9144289
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
- A Long-Term Observational Study of Immunologic Reconstitution in HIV-1 Infected Children Who Are Receiving Combination Protease Inhibitor and Reverse Transcriptase Inhibitors
- ClinicalTrials.gov ID
- NCT00001826
- Acronym / sponsor ID
- 990134
- Conditions
- HIV Infection
- Keywords
- CD-4-Naive T Cells, CD-4-Memory T Cells, Antiviral Activity, VB Repertoire, Immunizations, HIV, Treatment Experienced
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jul 1999
- Study completion
- May 2006
- First posted
- 4 Nov 1999 (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.
This study will continue to follow children who participated in an earlier National Cancer Institute trial of HIV treatment with a protease inhibitor. Children in this study will receive a combination of at least three drugs that include at least one protease inhibitor and one reverse transcriptase inhibitor.
The study will examine to what extent these drugs can restore immune function in HIV-infected children and over what length of time. It will look at changes in the amounts of virus and the specific types of immune cells in the body over the 96-week trial period. It will also examine patients' immune system response to influenza and tetanus vaccinations.
The children will either continue to receive the anti-HIV drugs they have been taking, or their medicines will be changed to a different combination of protease inhibitor and reverse transcriptase inhibitor. Before and during the study, patients will undergo various tests, including a physical examination, blood tests and chest X ray, immune response tests, CT scan, eye examination, electrocardiogram and echocardiogram. A procedure called apheresis may be done to collect white blood cells. In this procedure, whole blood is drawn similar to donating blood, the white cells are separated out by a machine, and the red cells are returned to the body.
Detailed description
This study will evaluate the extent of immunoreconstitution in children receiving combination antiretroviral therapy that includes a protease inhibitor and reverse transcriptase inhibitors. The children who will be evaluated and followed in this study are those who have previously been studied on other protease inhibitor-containing anti-HIV protocols within the HIV and AIDS Malignancy Branch. This study will provide a mechanism to assess the long-term immunologic changes of potent combination therapy in this unique population and to relate this to the virologic changes. A total of 50 HIV-1 infected children will be studied. The children enrolled in this protocol will either continue their current combination of protease inhibitor and reverse transcriptase therapy or, if deemed clinically appropriate, will be changed to a new, best available combination of protease inhibitor and reverse transcriptase inhibitors. Long-term immunoreconstitution, defined as the repopulation of naive CD4+T lymphocytes, will be studied by determining the presence and extent of production of new naive (thymic derived) CD4+T cells and by the ability of patients to mount new helper T cell responses after immunization with influenza and tetanus toxoid. Expansion of T cell receptor will also be explored in subsets of enrolled patients. In addition, unforeseen toxicities attributable to the use of combination antiretroviral therapy have been recognized and described in adult patients. This study will evaluate abnormalities in lipid and glucose metabolism, changes in the distribution of body fat, and surrogate markers of cardiovascular disease risk in this cohort of pediatric patients.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Age greater than 1 year and less than 21 years.
- Diagnosis of HIV-1 infection as defined by the Centers for Disease Control (CDC).
- Currently on at least a three drug combination that includes a protease inhibitor (PI) and reverse transcriptase inhibitor (RTI) therapy for at least 6 months.
- Patient must have received initial protease inhibitor treatment in studies in the HIV and AIDS Malignancy Branch but need not be enrolled on another NIH study to be eligible for this protocol.
- Age-adjusted CD4+ T lymphocytes greater than 200 cells/ml.
Key exclusion criteria (8 listed)
- Critically ill or clinically unstable child.
- Patients receiving treatment for an infection that requires prolonged treatment must have been stable on therapy for at least 14 days prior to study entry.
- Administration of chemotherapeutic agents or use of immunomodulating agents such as high dose corticosteroids, interferons, pentoxifylline, G-CSF/GM-CSF, erythropoietin, growth hormone and other growth factors within one month of enrollment. However, patients on anti-inflammatory drugs or stable doses of immunoglobulins (including hyperimmune immunoglobulin) will be eligible unless the latter are directed at a T-cell specific antigen.
- Sexually active post-menarchal female unwilling to use a barrier method of contraception or unwilling to remain sexually abstinent.
- may not be likely to benefit from this study,
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 8811347Clerici M, Shearer GM. Correlates of protection in HIV infection and the progression of HIV infection to AIDS. Immunol Lett. 1996 Jun;51(1-2):69-73. doi: 10.1016/0165-2478(96)02557-6.
- Background: PubMed 9669944Ho DD. Toward HIV eradication or remission: the tasks ahead. Science. 1998 Jun 19;280(5371):1866-7. doi: 10.1126/science.280.5371.1866. No abstract available.
- Background: PubMed 9144289Chun TW, Carruth L, Finzi D, Shen X, DiGiuseppe JA, Taylor H, Hermankova M, Chadwick K, Margolick J, Quinn TC, Kuo YH, Brookmeyer R, Zeiger MA, Barditch-Crovo P, Siliciano RF. Quantification of latent tissue reservoirs and total body viral load in HIV-1 infection. Nature. 1997 May 8;387(6629):183-8. doi: 10.1038/387183a0.
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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 7 inclusion and 8 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 NCT00001826, 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.