HIV InfectionsNCT00000896
A Study to Compare the Effectiveness of a Four Drug Anti-HIV Regimen Given Alone or in Combination With GM-CSF or IL-12 to HIV-Positive Patients
A study testing Indinavir sulfate, Lamivudine/Zidovudine and Hepatitis A Vaccine (Inactivated) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.
Trial summary
The purpose of this study is to examine how the level of HIV is reduced in the blood when anti-HIV therapy is initiated. This study will also evaluate whether adding GM-CSF or IL-12 to the anti-HIV drug regimen will increase the rate that HIV is reduced. 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, Lamivudine/Zidovudine and Hepatitis A Vaccine (Inactivated)
- Type of treatment
- Vaccines
- How many people
- 24 participants
- Where
- 3 sitesUnited States
- Study dates
- Start not givento Oct 2000
- 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
- You may be eligible for this study if you:
- Are HIV-positive.
- Have a CD4 cell count greater than or equal to 300 cells/ml within 30 days prior to study entry.
- Have a plasma viral load (level of HIV in the blood) of greater than or equal to 20,000 copies/ml within 30 days of study entry.
- Are at least 18 years old.
- Agree to practice abstinence or use effective methods of birth control during the study.
Who cannot join
- You will not be eligible for this study if you:
- Have taken anti-HIV medication for more than 7 days.
- Have had known seroconversion within 6 months prior to study entry.
- Have any infection requiring treatment within 30 days prior to study entry.
- Have had a fever for 7 days in a row during the 30 days before study entry.
- Have cancer that requires chemotherapy.
- Are pregnant or breast-feeding.
- Are taking certain medications.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Colorado Hospital CRS
Aurora, Colorado, 80262
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana
Ucsd, Avrc Crs
San Diego, California
About this study
Official title: A Randomized Controlled Trial to Compare the Efficacy of a Four Drug Antiretroviral Regimen Alone or in Combination With GM-CSF or IL-12 Administered to HIV-1 Infected Subjects as Measured by the Characteristics of Viral Decay
The purpose of this study is to examine how the level of HIV is reduced in the blood when anti-HIV therapy is initiated. This study will also evaluate whether adding GM-CSF or IL-12 to the anti-HIV drug regimen will increase the rate that HIV is reduced.
The anti-HIV drugs used in this study will include lamivudine (3TC), zidovudine (ZDV), indinavir (IDV), nevirapine (NVP), and stavudine (d4T). All have been used successfully to treat HIV. GM-CSF has been used to treat certain blood disorders; it will be used as an experimental drug in this study. IL-12 (interleukin-12) is a protein found naturally in the body that is thought to boost the immune system. Although GM-CSF and IL-12 have no direct effect against HIV, these drugs may improve the ability of the immune system to fight the virus.
Read the detailed description
Potent antiretroviral therapies that suppress HIV replication have permitted mathematical modeling of the dynamics of HIV infection and clearance by measurement of the decay of viral load in plasma. When de nova infection is blocked by antiretroviral therapy, the viral load decreases exponentially after a short initial lag time ("shoulder"). This rapid decline is followed by a slower second-phase decay. The intent of this study is to utilize four antiretroviral agents (zidovudine, lamivudine, nevirapine, indinavir) and very frequent measures of viral load to explore the drug-specific kinetics of the "shoulder". The decay of long-lived HIV-infected tissue macrophages is thought to be the major determinant of the slow second phase. Further, the study intends to use immune modulating agents with the potential to increase the turnover of infected macrophages, GM-CSF or IL-12, to accelerate the second phase of viral decay.
Patients are assigned to Group A (16 patients) or to Group B (8 patients). Patients in Group A are randomized to 1 of the following 4 initial treatment arms:
ARM A: Final dose combination (FDC) Zidovudine (ZDV)/Lamivudine (3TC). ARM B: Nevirapine (NVP). ARM C: Indinavir (IDV). ARM D: FDC ZDV/3TC plus NVP plus IDV. The initial regimen is maintained over the first 72 hours and blood for viral dynamic evaluations collected while patients are maintained as inpatients. Then, patients in Arms A, B, and C initiate FDC ZDV/3TC plus NVP plus IDV.
Patients assigned to Group B begin the following 4-drug regimen on Day 0:
ARM E: FDC ZDV/3TC plus NVP plus IDV.
On Day 7, patients in both Groups A and B are randomized to receive one of the following therapies in addition to their 4-drug regimen:
ARM F: GM-CSF daily for 2 weeks, then thrice weekly (MWF). ARM G: IL-12 twice weekly. ARM H: No immune modulation. Patients may be hospitalized to initiate immune modulation or may be treated as outpatients. Immune modulation is discontinued after Week 14. Patients maintain their 4-drug regimen through Week 48. [AS PER AMENDMENT 6/11/99: The study duration has been extended to 96 weeks.] Hepatitis A vaccine (inactivated) is administered on Weeks 16 and 40 [AS PER AMENDMENT 2/13/98: to patients whose baseline hepatitis A serology was negative].
- Conditions
- HIV Infections
- Being tested
- Indinavir sulfate, Lamivudine/Zidovudine, Hepatitis A Vaccine (Inactivated), Interleukin-12, Nevirapine
- Keywords
- HIV-1, Drug Therapy, Combination, Granulocyte Colony-Stimulating Factor, Acquired Immunodeficiency Syndrome, Zidovudine, Nevirapine, Stavudine, HIV Protease Inhibitors, Lamivudine, Indinavir, Interleukin-12, Reverse Transcriptase Inhibitors
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indinavir sulfateDrug
Lamivudine/ZidovudineDrug
Hepatitis A Vaccine (Inactivated)Biological
Interleukin-12Drug
NevirapineDrug
StavudineDrug
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 completionOct 2000
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
- Masking
- None (open label)
- Enrolment
- 24 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Rhonda G. Kost, Study chairDavid Ho, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000896
- Sponsor's protocol ID
- ACTG 387
- Other IDs
- 11346
- 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
- A Randomized Controlled Trial to Compare the Efficacy of a Four Drug Antiretroviral Regimen Alone or in Combination With GM-CSF or IL-12 Administered to HIV-1 Infected Subjects as Measured by the Characteristics of Viral Decay
- ClinicalTrials.gov ID
- NCT00000896
- Acronym / sponsor ID
- ACTG 387
- Conditions
- HIV Infections
- Keywords
- HIV-1, Drug Therapy, Combination, Granulocyte Colony-Stimulating Factor, Acquired Immunodeficiency Syndrome, Zidovudine, Nevirapine, Stavudine, HIV Protease Inhibitors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Oct 2000 (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 examine how the level of HIV is reduced in the blood when anti-HIV therapy is initiated. This study will also evaluate whether adding GM-CSF or IL-12 to the anti-HIV drug regimen will increase the rate that HIV is reduced.
The anti-HIV drugs used in this study will include lamivudine (3TC), zidovudine (ZDV), indinavir (IDV), nevirapine (NVP), and stavudine (d4T). All have been used successfully to treat HIV. GM-CSF has been used to treat certain blood disorders; it will be used as an experimental drug in this study. IL-12 (interleukin-12) is a protein found naturally in the body that is thought to boost the immune system. Although GM-CSF and IL-12 have no direct effect against HIV, these drugs may improve the ability of the immune system to fight the virus.
Detailed description
Potent antiretroviral therapies that suppress HIV replication have permitted mathematical modeling of the dynamics of HIV infection and clearance by measurement of the decay of viral load in plasma. When de nova infection is blocked by antiretroviral therapy, the viral load decreases exponentially after a short initial lag time ("shoulder"). This rapid decline is followed by a slower second-phase decay. The intent of this study is to utilize four antiretroviral agents (zidovudine, lamivudine, nevirapine, indinavir) and very frequent measures of viral load to explore the drug-specific kinetics of the "shoulder". The decay of long-lived HIV-infected tissue macrophages is thought to be the major determinant of the slow second phase. Further, the study intends to use immune modulating agents with the potential to increase the turnover of infected macrophages, GM-CSF or IL-12, to accelerate the second phase of viral decay.
Patients are assigned to Group A (16 patients) or to Group B (8 patients). Patients in Group A are randomized to 1 of the following 4 initial treatment arms:
ARM A: Final dose combination (FDC) Zidovudine (ZDV)/Lamivudine (3TC). ARM B: Nevirapine (NVP). ARM C: Indinavir (IDV). ARM D: FDC ZDV/3TC plus NVP plus IDV. The initial regimen is maintained over the first 72 hours and blood for viral dynamic evaluations collected while patients are maintained as inpatients. Then, patients in Arms A, B, and C initiate FDC ZDV/3TC plus NVP plus IDV.
Patients assigned to Group B begin the following 4-drug regimen on Day 0:
ARM E: FDC ZDV/3TC plus NVP plus IDV.
On Day 7, patients in both Groups A and B are randomized to receive one of the following therapies in addition to their 4-drug regimen:
ARM F: GM-CSF daily for 2 weeks, then thrice weekly (MWF). ARM G: IL-12 twice weekly. ARM H: No immune modulation. Patients may be hospitalized to initiate immune modulation or may be treated as outpatients. Immune modulation is discontinued after Week 14. Patients maintain their 4-drug regimen through Week 48. [AS PER AMENDMENT 6/11/99: The study duration has been extended to 96 weeks.] Hepatitis A vaccine (inactivated) is administered on Weeks 16 and 40 [AS PER AMENDMENT 2/13/98: to patients whose baseline hepatitis A serology was negative].
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Are HIV-positive.
- Have a CD4 cell count greater than or equal to 300 cells/ml within 30 days prior to study entry.
- Have a plasma viral load (level of HIV in the blood) of greater than or equal to 20,000 copies/ml within 30 days of study entry.
- Are at least 18 years old.
- Agree to practice abstinence or use effective methods of birth control during the study.
Key exclusion criteria (8 listed)
- Have taken anti-HIV medication for more than 7 days.
- Have had known seroconversion within 6 months prior to study entry.
- Have any infection requiring treatment within 30 days prior to study entry.
- Have had a fever for 7 days in a row during the 30 days before study entry.
- Have cancer that requires chemotherapy.
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 | – |
| Lamivudine/Zidovudine | Drug | – |
| Hepatitis A Vaccine (Inactivated) | Biological | – |
| Interleukin-12 | Drug | – |
| Nevirapine | Drug | – |
| Stavudine | 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.
Rhonda G. Kost study chair
David Ho study chair
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indinavir sulfate, Lamivudine/Zidovudine and Hepatitis A Vaccine (Inactivated) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 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 6 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 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 3 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 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.