HIV InfectionsNCT00084032
Anti-HIV Medications and Structured Treatment Interruptions for People Recently Infected With HIV
A study testing Structured treatment interruption and Antiretroviral regimen in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID).
Trial summary
People recently infected with HIV who are treated with anti-HIV medications may develop strong immune system responses to HIV and may be able to control the virus without continuing to take these medications. 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?
- Structured treatment interruption and Antiretroviral regimen
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- 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
- Acute or early HIV infection as defined by the study
- Agrees to use acceptable methods of contraception
- Agrees to begin antiretroviral treatment regimen within 21 days of diagnosis and no more than 3 days after study entry
Who cannot join
- Unwilling to follow random assignment in Step 2
- Abnormal laboratory result within 21 days prior to study entry, unless abnormality is considered part of acute HIV infection
- Have taken antiretroviral drugs other than for postexposure prophylaxis (PEP). Patients who have undergone up to 30 days of previous PEP treatment are not excluded.
- Pregnancy or breastfeeding
- Previous participation in an HIV vaccine trial
- Previous use of experimental therapeutic immunizations or cytokine infusions
Show all 19Show fewer
- Inclusion Criteria for Participants Enrolling Directly into Step 2:
- Viral load of less than 400 copies/ml
- Enrolled in the AIEDRP CORE01 study, with stored blood samples obtained within 21 days prior to starting treatment on CORE01
- Currently receiving antiretroviral treatment regimen, with no interruptions for more than 7 consecutive days since the beginning of treatment
- Antiretroviral treatment was started within 21 days after HIV diagnosis
- Agrees to use acceptable methods of contraception
- Unwilling to follow random assignment to study arms and follow scheduled treatment interruptions
- More than 52 weeks of ARV treatment since diagnosis of acute/early HIV infection prior to entering Step 2
- CD4 count less than 350 cells/mm3 within 28 days of entry into Step 2
- AIDS-defining illness
- Pregnant or breastfeeding
- Previous participation in an HIV vaccine trial
- Previous use of experimental therapeutic immunizations or cytokine infusions
About this study
Official title: A Randomized, Multicenter Trial to Determine Whether Induction Therapy Followed by Treatment Interruption is Superior to Induction Therapy Alone in the Treatment of Primary HIV Infection (PHI): The Structured Treatment Interruption (STI) Study
People recently infected with HIV who are treated with anti-HIV medications may develop strong immune system responses to HIV and may be able to control the virus without continuing to take these medications. The purpose of this study is to see if giving anti-HIV medications to people soon after they have been infected with HIV can help them control HIV. The study will also see if the immune system can control the amount of HIV virus in the blood (viral load) even after a person has stopped taking the medications. The study will evaluate three different schedules of stopping and starting anti-HIV medications to see which schedule is best able to boost a patient's immune system to control HIV viral load.
Hypothesis: Combination therapy started in primary HIV infection, in conjunction with structured treatment interruptions, will result in greater control of viremia off treatment than induction therapy alone.
Read the detailed description
Initiation of treatment during acute HIV infection seems to result in greater suppression of viral replication than noted during chronic infection and better recovery of certain CD4 subpopulations. However, it is difficult for patients treated during acute infection to maintain long-term continuous antiretroviral (ARV) treatment because of difficulty adhering to complicated medication regimens, drug-related toxicities, and cost of medications. Acutely infected patients who have undergone early initiation of treatment followed by structured treatment interruptions (STIs) appear to have lower off-treatment viral loads than historical controls. This study will evaluate whether effective ARV treatment during acute and early HIV infection followed by STI will result in lower viral setpoints than would otherwise be expected.
This trial will have 2 steps and will last for a maximum of 104 weeks. Participants will either enter Step 1 and continue on to Step 2 or enter Step 2 directly. During Step 1, participants with acute or early HIV infection will be given 24 weeks of ARV therapy. Participants may take any combination of FDA-approved ARV medications that they and their doctors select. Participants will have study visits at study entry and Weeks 1, 4, 8, and 20. After 24 weeks on Step 1, participants may enroll in Step 2.
Participants in Step 1 and people with early or acute HIV infection who began ARV treatment within 21 days of diagnosis and have had no more than 1 year of treatment may enroll in Step 2. During Step 2, participants will be randomly assigned to one of two study arms:
- Arm 1: Participants will continue taking ARV therapy for 16 weeks and then stop ARVs for 64 weeks.
- Arm 2: Participants will stop ARVs for 4 weeks, take ARVs for 8 weeks, stop ARVs for 4 weeks, take ARVs for 8 weeks, and then stop ARVs for 56 weeks.
Participants in both study arms will restart ARVs regardless of STI duration if their viral load is above 50,000 copies/ml, they progress to CDC category C disease, or their CD4 count falls below 350 cells/mm3 or declines more than 50% from the last on-treatment CD4 level.
Step 2 will last 80 weeks. For the first year, participants will have study visits every 1 to 4 weeks, depending on whether they are taking ARVs. During the second year, participants will have study visits every 8 weeks. Study visits will include a brief medical history, blood and pregnancy tests, and voluntary behavioral questionnaires.
- Conditions
- HIV Infections
- Being tested
- Structured treatment interruption, Antiretroviral regimen
- Keywords
- Acute Infection, Treatment Interruption, Treatment Naive, Primary HIV Infection, PHI
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured treatment interruptionBehavioural
Treatment interruption schedule is dependent on the Arm in which participants are enrolled in Step 2
Antiretroviral regimenDrug
Participants will take any combination of FDA-approved ARV medications prescribed by their physician
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | In Step 1, participants will receive ARV therapy for 24 weeks. Upon entering Step 2, participants will continue taking ARV therapy for 16 weeks and then stop ARVs for 64 weeks. Receives: Behavioral: Structured treatment interruption; Drug: Antiretroviral regimen |
| 2 | Experimental | In Step 1, participants will receive ARV therapy for 24 weeks. Upon entering Step 2, participants will stop ARVs for 4 weeks, take ARVs for 8 weeks, stop ARVs for 4 weeks, take ARVs for 8 weeks, and then stop ARVs for 56 weeks. Receives: Behavioral: Structured treatment interruption; Drug: Antiretroviral regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in mean HIV viral load between arms
Measured: At Week 80
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2004 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Eric Rosenberg, MD, Study chair, Massachusetts General HospitalDon Smith, MB, ChB, MD, Study chair, University of New South Wales, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00084032
- Sponsor's protocol ID
- AIEDRP AIN502
- Status last verified
- Oct 2012
- First submitted
- 4 Jun 2004
- Last updated
- 29 Oct 2012
- Results posted
- No
Publications
Girard PM, Schneider V, Dehee A, Mariot P, Jacomet C, Delphin N, Damond F, Carcelain G, Autran B, Saimot AG, Nicolas JC, Rozenbaum W. Treatment interruption after one year of triple nucleoside analogue therapy for primary HIV infection. AIDS. 2001 Jan 26;15(2):275-7. doi: 10.1097/00002030-200101260-00020. No abstract available.
PubMed 11216939Kaufmann GR, Zaunders JJ, Cunningham P, Kelleher AD, Grey P, Smith D, Carr A, Cooper DA. Rapid restoration of CD4 T cell subsets in subjects receiving antiretroviral therapy during primary HIV-1 infection. AIDS. 2000 Dec 1;14(17):2643-51. doi: 10.1097/00002030-200012010-00003.
PubMed 11125882Malhotra U, Berrey MM, Huang Y, Markee J, Brown DJ, Ap S, Musey L, Schacker T, Corey L, McElrath MJ. Effect of combination antiretroviral therapy on T-cell immunity in acute human immunodeficiency virus type 1 infection. J Infect Dis. 2000 Jan;181(1):121-31. doi: 10.1086/315202.
PubMed 10608758Markowitz M, Jin X, Hurley A, Simon V, Ramratnam B, Louie M, Deschenes GR, Ramanathan M Jr, Barsoum S, Vanderhoeven J, He T, Chung C, Murray J, Perelson AS, Zhang L, Ho DD. Discontinuation of antiretroviral therapy commenced early during the course of human immunodeficiency virus type 1 infection, with or without adjunctive vaccination. J Infect Dis. 2002 Sep 1;186(5):634-43. doi: 10.1086/342559. Epub 2002 Aug 9.
PubMed 12195350Walensky RP, Goldie SJ, Sax PE, Weinstein MC, Paltiel AD, Kimmel AD, Seage GR 3rd, Losina E, Zhang H, Islam R, Freedberg KA. Treatment for primary HIV infection: projecting outcomes of immediate, interrupted, or delayed therapy. J Acquir Immune Defic Syndr. 2002 Sep 1;31(1):27-37. doi: 10.1097/00126334-200209010-00004.
PubMed 12352147
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter Trial to Determine Whether Induction Therapy Followed by Treatment Interruption is Superior to Induction Therapy Alone in the Treatment of Primary HIV Infection (PHI): The Structured Treatment Interruption (STI) Study
- ClinicalTrials.gov ID
- NCT00084032
- Acronym / sponsor ID
- AIEDRP AIN502
- Conditions
- HIV Infections
- Keywords
- Acute Infection, Treatment Interruption, Treatment Naive, Primary HIV Infection, PHI
- 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
- 7 Jun 2004 (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.
People recently infected with HIV who are treated with anti-HIV medications may develop strong immune system responses to HIV and may be able to control the virus without continuing to take these medications. The purpose of this study is to see if giving anti-HIV medications to people soon after they have been infected with HIV can help them control HIV. The study will also see if the immune system can control the amount of HIV virus in the blood (viral load) even after a person has stopped taking the medications. The study will evaluate three different schedules of stopping and starting anti-HIV medications to see which schedule is best able to boost a patient's immune system to control HIV viral load.
Hypothesis: Combination therapy started in primary HIV infection, in conjunction with structured treatment interruptions, will result in greater control of viremia off treatment than induction therapy alone.
Detailed description
Initiation of treatment during acute HIV infection seems to result in greater suppression of viral replication than noted during chronic infection and better recovery of certain CD4 subpopulations. However, it is difficult for patients treated during acute infection to maintain long-term continuous antiretroviral (ARV) treatment because of difficulty adhering to complicated medication regimens, drug-related toxicities, and cost of medications. Acutely infected patients who have undergone early initiation of treatment followed by structured treatment interruptions (STIs) appear to have lower off-treatment viral loads than historical controls. This study will evaluate whether effective ARV treatment during acute and early HIV infection followed by STI will result in lower viral setpoints than would otherwise be expected.
This trial will have 2 steps and will last for a maximum of 104 weeks. Participants will either enter Step 1 and continue on to Step 2 or enter Step 2 directly. During Step 1, participants with acute or early HIV infection will be given 24 weeks of ARV therapy. Participants may take any combination of FDA-approved ARV medications that they and their doctors select. Participants will have study visits at study entry and Weeks 1, 4, 8, and 20. After 24 weeks on Step 1, participants may enroll in Step 2.
Participants in Step 1 and people with early or acute HIV infection who began ARV treatment within 21 days of diagnosis and have had no more than 1 year of treatment may enroll in Step 2. During Step 2, participants will be randomly assigned to one of two study arms:
- Arm 1: Participants will continue taking ARV therapy for 16 weeks and then stop ARVs for 64 weeks.
- Arm 2: Participants will stop ARVs for 4 weeks, take ARVs for 8 weeks, stop ARVs for 4 weeks, take ARVs for 8 weeks, and then stop ARVs for 56 weeks.
Participants in both study arms will restart ARVs regardless of STI duration if their viral load is above 50,000 copies/ml, they progress to CDC category C disease, or their CD4 count falls below 350 cells/mm3 or declines more than 50% from the last on-treatment CD4 level.
Step 2 will last 80 weeks. For the first year, participants will have study visits every 1 to 4 weeks, depending on whether they are taking ARVs. During the second year, participants will have study visits every 8 weeks. Study visits will include a brief medical history, blood and pregnancy tests, and voluntary behavioral questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Structured treatment interruption, Drug: Antiretroviral regimenIn Step 1, participants will receive ARV therapy for 24 weeks. Upon entering Step 2, participants will continue taking ARV therapy for 16 weeks and then stop ARVs for 64 weeks. |
| 2 | Experimental | Behavioral: Structured treatment interruption, Drug: Antiretroviral regimenIn Step 1, participants will receive ARV therapy for 24 weeks. Upon entering Step 2, participants will stop ARVs for 4 weeks, take ARVs for 8 weeks, stop ARVs for 4 weeks, take ARVs for 8 weeks, and then stop ARVs for 56 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acute or early HIV infection as defined by the study
- Agrees to use acceptable methods of contraception
- Agrees to begin antiretroviral treatment regimen within 21 days of diagnosis and no more than 3 days after study entry
Key exclusion criteria (19 listed)
- Unwilling to follow random assignment in Step 2
- Abnormal laboratory result within 21 days prior to study entry, unless abnormality is considered part of acute HIV infection
- Have taken antiretroviral drugs other than for postexposure prophylaxis (PEP). Patients who have undergone up to 30 days of previous PEP treatment are not excluded.
- Pregnancy or breastfeeding
- Previous participation in an HIV vaccine trial
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 |
|---|---|---|
| Structured treatment interruptionTreatment interruption schedule is dependent on the Arm in which participants are enrolled in Step 2 | Behavioural | 1, 2 |
| Antiretroviral regimenParticipants will take any combination of FDA-approved ARV medications prescribed by their physician | Drug | 1, 2 |
Primary outcome
Difference in mean HIV viral load between arms
Time frame: At Week 80
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 29 Oct 2012.
- Background: PubMed 11216939Girard PM, Schneider V, Dehee A, Mariot P, Jacomet C, Delphin N, Damond F, Carcelain G, Autran B, Saimot AG, Nicolas JC, Rozenbaum W. Treatment interruption after one year of triple nucleoside analogue therapy for primary HIV infection. AIDS. 2001 Jan 26;15(2):275-7. doi: 10.1097/00002030-200101260-00020. No abstract available.
- Background: PubMed 11125882Kaufmann GR, Zaunders JJ, Cunningham P, Kelleher AD, Grey P, Smith D, Carr A, Cooper DA. Rapid restoration of CD4 T cell subsets in subjects receiving antiretroviral therapy during primary HIV-1 infection. AIDS. 2000 Dec 1;14(17):2643-51. doi: 10.1097/00002030-200012010-00003.
- Background: PubMed 10608758Malhotra U, Berrey MM, Huang Y, Markee J, Brown DJ, Ap S, Musey L, Schacker T, Corey L, McElrath MJ. Effect of combination antiretroviral therapy on T-cell immunity in acute human immunodeficiency virus type 1 infection. J Infect Dis. 2000 Jan;181(1):121-31. doi: 10.1086/315202.
- Background: PubMed 12195350Markowitz M, Jin X, Hurley A, Simon V, Ramratnam B, Louie M, Deschenes GR, Ramanathan M Jr, Barsoum S, Vanderhoeven J, He T, Chung C, Murray J, Perelson AS, Zhang L, Ho DD. Discontinuation of antiretroviral therapy commenced early during the course of human immunodeficiency virus type 1 infection, with or without adjunctive vaccination. J Infect Dis. 2002 Sep 1;186(5):634-43. doi: 10.1086/342559. Epub 2002 Aug 9.
- Background: PubMed 12352147Walensky RP, Goldie SJ, Sax PE, Weinstein MC, Paltiel AD, Kimmel AD, Seage GR 3rd, Losina E, Zhang H, Islam R, Freedberg KA. Treatment for primary HIV infection: projecting outcomes of immediate, interrupted, or delayed therapy. J Acquir Immune Defic Syndr. 2002 Sep 1;31(1):27-37. doi: 10.1097/00126334-200209010-00004.
- Click here for more information on AIEDRP CORE01Link provided by the sponsor.
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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.
Eric Rosenberg, MD study chair
Massachusetts General Hospital
Don Smith, MB, ChB, MD study chair
University of New South Wales, Australia
Questions about this trial
What is this clinical trial studying?
A study testing Structured treatment interruption and Antiretroviral regimen in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID).
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 19 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 29 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
Difference in mean HIV viral load between arms (time frame: At Week 80). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00084032, which also lists 5 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 29 Oct 2012.