HIV InfectionsPhase 2NCT00000850
The Effectiveness of GM-CSF in HIV-Positive Patients Who Are Also Receiving Anti-HIV Therapy
A Phase 2 study testing Indinavir sulfate and Sargramostim in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 39 sites in United States.
Trial summary
The purpose of this study is to see how HIV-positive patients who are taking anti-HIV drugs and have a viral load (level of HIV in the blood) of 1,500 copies/ml or more respond to GM-CSF (granulocyte-macrophage colony-stimulating factor). 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?
- Indinavir sulfate and Sargramostim
- How many people
- 108 participants
- Where
- 39 sitesUnited States
- Study dates
- Start not givento Dec 2003
- Phase
- Phase 2
- 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.
- Have a stable viral load of at least 1,500 copies/ml within 30 days of study entry.
- Are on stable aggressive anti-HIV therapy for at least 8 weeks before study entry and intend to remain on this therapy during the study.
- Agree to learn how to give themselves the GM-CSF shots.
- Agree to practice acceptable barrier methods of birth control (such as condoms) during the study and for at least 12 weeks after treatment ends.
- Are at least 18 years old.
Who cannot join
- Patients will not be eligible for this study if they:
- Have an infection or other illness within 14 days of study entry.
- Have certain types of hepatitis within 30 days of study entry.
- Have a fever or chronic diarrhea within 30 days of study entry.
- Have cancer (except for certain types of Kaposi's sarcoma).
- Have heart disease.
Show all 9Show fewer
- Are allergic to GM-CSF.
- Have received certain medications.
- Are pregnant or breast-feeding.
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
United States39 sites
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
Boston Med Ctr
Boston, Massachusetts, 02118
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
Northwestern Univ Med School
Chicago, Illinois, 60611
Cook County Hosp
Chicago, Illinois, 60612
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
Case Western Reserve Univ
Cleveland, Ohio, 44106
MetroHealth Med Ctr
Cleveland, Ohio, 441091998
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
Duke Univ Med Ctr
Durham, North Carolina, 27710
Univ of Texas Galveston
Galveston, Texas, 775550435
Univ of Hawaii
Honolulu, Hawaii, 96816
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, 46202
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202
Kaiser Permanente LAMC
Los Angeles, California, 90027
UCLA CARE Ctr
Los Angeles, California, 90095
Willow Clinic
Menlo Park, California, 94025
Univ of Miami School of Medicine
Miami, Florida, 331361013
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016
Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ
New York, New York, 10021
Chelsea Ctr
New York, New York, 10021
Cornell Univ Med Ctr
New York, New York, 10021
Mount Sinai Med Ctr
New York, New York, 10029
Columbia Presbyterian Med Ctr
New York, New York, 10032
Philadelphia Veterans Administration Med Ctr
Philadelphia, Pennsylvania, 19104
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
San Francisco Gen Hosp
San Francisco, California, 941102859
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose, California, 951282699
Marin County Specialty Clinic
San Rafael, California, 94903
Univ of Washington
Seattle, Washington, 98104
St Louis Regional Hosp / St Louis Regional Med Ctr
St Louis, Missouri, 63112
San Mateo AIDS Program / Stanford Univ
Stanford, California, 943055107
Stanford Univ Med Ctr
Stanford, California, 943055107
Harbor UCLA Med Ctr
Torrance, California, 90502
Julio Arroyo
West Columbia, South Carolina, 29169
About this study
Official title: The Effects of GM-CSF on Plasma HIV-1 RNA and Chemokine Receptor Expression in HIV-1 Infected Subjects Receiving Concomitant Potent Antiretroviral Therapy
The purpose of this study is to see how HIV-positive patients who are taking anti-HIV drugs and have a viral load (level of HIV in the blood) of 1,500 copies/ml or more respond to GM-CSF (granulocyte-macrophage colony-stimulating factor).
GM-CSF is a medication that is being tested in HIV-positive patients to see if it can improve their immune systems or if it can lower the level of HIV in their blood. GM-CSF is often given to patients with leukemia or patients who have received bone marrow transplants to increase their white blood cells and to improve their immune systems. Doctors believe that GM-CSF can increase CD4 counts in HIV-positive patients, but this study will also look at how GM-CSF affects viral load.
Read the detailed description
GM-CSF promotes the differentiation and activation of granulocytes, monocytes, macrophages, and dendritic cells and enhances the function of these cells. The various cellular responses (i.e., division, maturation, activation) are induced when GM-CSF binds to specific receptors expressed on the surface of target cells. At higher doses, such as the dose used in this protocol, GM-CSF may result in a rapid rise in white blood cell count. However, further research is necessary to determine the potential antiviral effect of GM-CSF in a potent ART-treated population. It is hoped that GM-CSF can decrease the extent of ongoing HIV replication via alteration of macrophage activation and chemokine receptor expression and that this effect can result in reduction of the pool of latently infected T cells.
Patients are stratified at study entry according to screening CD4 count (below 200 cells/mm3 versus 200 cells/mm3 or higher) and screening HIV-1 RNA copy number (between 1,500 and 10,000 versus 10,000 copies/ml or higher). Then, patients are randomized to receive GM-CSF or GM-CSF placebo subcutaneously 3 times per week for 16 weeks. All patients remain on their current stable potent ART (not provided by this study). During Step 2, all patients receive open-label study treatment, consisting of current potent ART plus GM-CSF subcutaneously 3 times per week for 32 additional weeks. HIV-1 RNA, CD4 counts, and clinical and safety parameters are monitored for all patients periodically until Week 52. Patients who experience an increase in HIV-1 RNA of greater than 1 log 10 from baseline on 2 consecutive determinations or a greater than 50% decrease in CD4 count from baseline (a drop of at least 50 cells) on 2 consecutive determinations at any time during Step 1 or 2 must discontinue all study treatment. Patients who discontinue study treatment for any reason prior to Week 16 continue following the study visit schedule through Week 16.
Additional laboratory samples are performed on patients participating in the immunology substudy (ACTG A5042s) in order to further evaluate the effects of GM-CSF on immune function.
- Conditions
- HIV Infections
- Being tested
- Indinavir sulfate, Sargramostim
- Keywords
- HIV-1, Granulocyte-Macrophage Colony-Stimulating Factor, RNA, Viral, Anti-HIV Agents, Viral Load, Receptors, Chemokine
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indinavir sulfateDrug
SargramostimDrug
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)
- Study completionDec 2003
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 2
- Primary purpose
- Treatment
- Enrolment
- 108 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Jeffrey Jacobson, Study chairGail Skowron, Study chairPablo Tebas, Study chairHernan Valdez, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000850
- Sponsor's protocol ID
- A5041
- Other IDs
- AACTG A5041, 10887, ACTG A5041
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 29 Oct 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of GM-CSF on Plasma HIV-1 RNA and Chemokine Receptor Expression in HIV-1 Infected Subjects Receiving Concomitant Potent Antiretroviral Therapy
- ClinicalTrials.gov ID
- NCT00000850
- Acronym / sponsor ID
- A5041
- Conditions
- HIV Infections
- Keywords
- HIV-1, Granulocyte-Macrophage Colony-Stimulating Factor, RNA, Viral, Anti-HIV Agents, Viral Load, Receptors, Chemokine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Dec 2003 (actual)
- 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 how HIV-positive patients who are taking anti-HIV drugs and have a viral load (level of HIV in the blood) of 1,500 copies/ml or more respond to GM-CSF (granulocyte-macrophage colony-stimulating factor).
GM-CSF is a medication that is being tested in HIV-positive patients to see if it can improve their immune systems or if it can lower the level of HIV in their blood. GM-CSF is often given to patients with leukemia or patients who have received bone marrow transplants to increase their white blood cells and to improve their immune systems. Doctors believe that GM-CSF can increase CD4 counts in HIV-positive patients, but this study will also look at how GM-CSF affects viral load.
Detailed description
GM-CSF promotes the differentiation and activation of granulocytes, monocytes, macrophages, and dendritic cells and enhances the function of these cells. The various cellular responses (i.e., division, maturation, activation) are induced when GM-CSF binds to specific receptors expressed on the surface of target cells. At higher doses, such as the dose used in this protocol, GM-CSF may result in a rapid rise in white blood cell count. However, further research is necessary to determine the potential antiviral effect of GM-CSF in a potent ART-treated population. It is hoped that GM-CSF can decrease the extent of ongoing HIV replication via alteration of macrophage activation and chemokine receptor expression and that this effect can result in reduction of the pool of latently infected T cells.
Patients are stratified at study entry according to screening CD4 count (below 200 cells/mm3 versus 200 cells/mm3 or higher) and screening HIV-1 RNA copy number (between 1,500 and 10,000 versus 10,000 copies/ml or higher). Then, patients are randomized to receive GM-CSF or GM-CSF placebo subcutaneously 3 times per week for 16 weeks. All patients remain on their current stable potent ART (not provided by this study). During Step 2, all patients receive open-label study treatment, consisting of current potent ART plus GM-CSF subcutaneously 3 times per week for 32 additional weeks. HIV-1 RNA, CD4 counts, and clinical and safety parameters are monitored for all patients periodically until Week 52. Patients who experience an increase in HIV-1 RNA of greater than 1 log 10 from baseline on 2 consecutive determinations or a greater than 50% decrease in CD4 count from baseline (a drop of at least 50 cells) on 2 consecutive determinations at any time during Step 1 or 2 must discontinue all study treatment. Patients who discontinue study treatment for any reason prior to Week 16 continue following the study visit schedule through Week 16.
Additional laboratory samples are performed on patients participating in the immunology substudy (ACTG A5042s) in order to further evaluate the effects of GM-CSF on immune function.
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 (7 listed)
- Are HIV-positive.
- Have a stable viral load of at least 1,500 copies/ml within 30 days of study entry.
- Are on stable aggressive anti-HIV therapy for at least 8 weeks before study entry and intend to remain on this therapy during the study.
- Agree to learn how to give themselves the GM-CSF shots.
- Agree to practice acceptable barrier methods of birth control (such as condoms) during the study and for at least 12 weeks after treatment ends.
Key exclusion criteria (9 listed)
- Have an infection or other illness within 14 days of study entry.
- Have certain types of hepatitis within 30 days of study entry.
- Have a fever or chronic diarrhea within 30 days of study entry.
- Have cancer (except for certain types of Kaposi's sarcoma).
- Have heart disease.
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 |
|---|---|---|
| Indinavir sulfate | Drug | – |
| Sargramostim | Drug | – |
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 29 Oct 2021.
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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.
Jeffrey Jacobson study chair
Gail Skowron study chair
Pablo Tebas study chair
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Indinavir sulfate and Sargramostim in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 39 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 7 inclusion and 9 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 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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 29 Oct 2021.