HIV InfectionsNCT00006578
Evaluation of Specific Infection-Fighting Cells For Prediction of Immune Response to Anti-HIV and Immune-Boosting Medication
A study testing Ritonavir, Abacavir sulfate and Amprenavir in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in United States.
Trial summary
The purpose of this study is to see if the amount of stem cells (cells that can develop into many kinds of cells) in the blood before anti-HIV drugs are taken can predict if the immune system will become stronger after anti-HIV drugs are given and if anti-HIV drugs can restore stem cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Ritonavir, Abacavir sulfate and Amprenavir
- How many people
- 0 participants
- Where
- 5 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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
Who may be able to join
- Patients may be eligible for this study if they:
- Are HIV-positive.
- Are at least 18 years of age.
- Have HIV levels of at least 1,000 copies/ml within 28 days prior to study entry.
- Have a CD4 cell count of 500 cells/mm3 or less in the 28 days prior to study entry.
- Have not had anti-HIV therapy or have had no more than 2 weeks of prior anti-HIV therapy 90 days prior to study entry.
- Are a good candidate for anti-HIV therapy.
- Agree to abstinence or use a barrier method of birth control during the study and for 12 weeks afterward.
Who cannot join
- Patients will not be eligible for this study if they:
- Are pregnant or breast-feeding.
- Have ever had cancer.
- Have used G-CSF or GM-CSF within 180 days prior to study entry.
- Are allergic to E. coli products (such as insulin or human growth hormone).
- Abuse drugs or alcohol.
- Are receiving or have had, within 14 days prior to study entry, treatment for an opportunistic (AIDS-related) infection.
- Have a medical condition that would interfere with the study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
Northwestern Univ Med School
Chicago, Illinois, 60611
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
Univ of Miami School of Medicine
Miami, Florida, 331361013
About this study
Official title: Evaluation of the Relationship Between Immunologic Recovery After Highly Active Antiretroviral Therapy and the Ability to Mobilize CD34+ Stem Cells Following G-CSF Administration
The purpose of this study is to see if the amount of stem cells (cells that can develop into many kinds of cells) in the blood before anti-HIV drugs are taken can predict if the immune system will become stronger after anti-HIV drugs are given and if anti-HIV drugs can restore stem cells.
HIV infection has been shown to cause stem cells not to function well. Granulocyte colony-stimulating factor (G-CSF), which causes stem cells to go from the bone marrow (tissues in the bones where blood cells are formed) into the bloodstream, could possibly help boost immunity after anti-HIV treatment. This study examines the effects of G-CSF in helping the immune system become stronger after beginning anti-HIV treatment.
Read the detailed description
In HIV infection, a progressive decline and/or dysfunction of several cell types is seen. It is thought that stem cell dysfunction or destruction may contribute to the hematologic and immunologic perturbations characteristic of HIV infection and may possibly limit the extent of immunologic recovery following HAART. This study proposes to investigate whether stem cell function and reserves are important in determining the extent of immune reconstitution following HAART.
Patients are stratified according to CD4 count. On Day 0, patients receive a 7-day cycle of subcutaneous granulocyte colony-stimulating factor (G-CSF). Blood samples are collected regularly, and on Day 14 patients undergo real-time HIV-1 RNA determinations. On Day 28, or sooner if HIV RNA is at least 1 log above baseline on Day 14, HAART consisting of daily receipt of abacavir, lamivudine, amprenavir, and ritonavir is initiated and continues until Week 76. Patients who achieve viral suppression (below 400 copies/ml of plasma HIV-1 RNA) by Week 26 are eligible to receive a second 7-day cycle of G-CSF at Week 28 and, if viral suppression continues through Week 50, a third cycle of G-CSF at Week 52. Patients are followed every 8 weeks for changes in viral load. Additionally, patients are monitored at regular intervals for surrogate markers of immunologic recovery and, during each cycle of G-CSF, for measurements of stem cell mobilization. Patients may also volunteer for A5085s (Bone Marrow Aspirate Substudy) at participating sites.
- Conditions
- HIV Infections
- Being tested
- Ritonavir, Abacavir sulfate, Amprenavir, Lamivudine, Filgrastim
- Keywords
- Drug Therapy, Combination, Granulocyte Colony-Stimulating Factor, HIV Protease Inhibitors, Ritonavir, Lamivudine, Stem Cells, VX 478, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Antigens, CD34, abacavir, Treatment Naive
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RitonavirDrug
Abacavir sulfateDrug
AmprenavirDrug
LamivudineDrug
FilgrastimDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
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 National Institute of Allergy and Infectious Diseases (NIAID)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Cara Wilson, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006578
- Sponsor's protocol ID
- ACTG A5072
- Other IDs
- AACTG A5072, Substudy ACTG A5085s
- Status last verified
- Jun 2003
- First submitted
- 1 Dec 2000
- Last updated
- 9 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Immunologic Recovery After Highly Active Antiretroviral Therapy and the Ability to Mobilize CD34+ Stem Cells Following G-CSF Administration
- ClinicalTrials.gov ID
- NCT00006578
- Acronym / sponsor ID
- ACTG A5072
- Conditions
- HIV Infections
- Keywords
- Drug Therapy, Combination, Granulocyte Colony-Stimulating Factor, HIV Protease Inhibitors, Ritonavir, Lamivudine, Stem Cells, VX 478, Reverse Transcriptase Inhibitors
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- First posted
- 31 Aug 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.
The purpose of this study is to see if the amount of stem cells (cells that can develop into many kinds of cells) in the blood before anti-HIV drugs are taken can predict if the immune system will become stronger after anti-HIV drugs are given and if anti-HIV drugs can restore stem cells.
HIV infection has been shown to cause stem cells not to function well. Granulocyte colony-stimulating factor (G-CSF), which causes stem cells to go from the bone marrow (tissues in the bones where blood cells are formed) into the bloodstream, could possibly help boost immunity after anti-HIV treatment. This study examines the effects of G-CSF in helping the immune system become stronger after beginning anti-HIV treatment.
Detailed description
In HIV infection, a progressive decline and/or dysfunction of several cell types is seen. It is thought that stem cell dysfunction or destruction may contribute to the hematologic and immunologic perturbations characteristic of HIV infection and may possibly limit the extent of immunologic recovery following HAART. This study proposes to investigate whether stem cell function and reserves are important in determining the extent of immune reconstitution following HAART.
Patients are stratified according to CD4 count. On Day 0, patients receive a 7-day cycle of subcutaneous granulocyte colony-stimulating factor (G-CSF). Blood samples are collected regularly, and on Day 14 patients undergo real-time HIV-1 RNA determinations. On Day 28, or sooner if HIV RNA is at least 1 log above baseline on Day 14, HAART consisting of daily receipt of abacavir, lamivudine, amprenavir, and ritonavir is initiated and continues until Week 76. Patients who achieve viral suppression (below 400 copies/ml of plasma HIV-1 RNA) by Week 26 are eligible to receive a second 7-day cycle of G-CSF at Week 28 and, if viral suppression continues through Week 50, a third cycle of G-CSF at Week 52. Patients are followed every 8 weeks for changes in viral load. Additionally, patients are monitored at regular intervals for surrogate markers of immunologic recovery and, during each cycle of G-CSF, for measurements of stem cell mobilization. Patients may also volunteer for A5085s (Bone Marrow Aspirate Substudy) at participating sites.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Are HIV-positive.
- Are at least 18 years of age.
- Have HIV levels of at least 1,000 copies/ml within 28 days prior to study entry.
- Have a CD4 cell count of 500 cells/mm3 or less in the 28 days prior to study entry.
- Have not had anti-HIV therapy or have had no more than 2 weeks of prior anti-HIV therapy 90 days prior to study entry.
Key exclusion criteria (8 listed)
- Are pregnant or breast-feeding.
- Have ever had cancer.
- Have used G-CSF or GM-CSF within 180 days prior to study entry.
- Are allergic to E. coli products (such as insulin or human growth hormone).
- Abuse drugs or alcohol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ritonavir | Drug | – |
| Abacavir sulfate | Drug | – |
| Amprenavir | Drug | – |
| Lamivudine | Drug | – |
| Filgrastim | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2015.
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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.
Cara Wilson study chair
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ritonavir, Abacavir sulfate and Amprenavir in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites 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 8 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: withdrawn, as of the sponsor's last update on 9 Mar 2015. 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 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 was withdrawn before enrolling participants, so there are no results.
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 9 Mar 2015; AzTrials last refreshed its copy on 8 Nov 2026.