HIV InfectionsNCT00067574
Treatment Plan to Decrease Drug Exposure in HIV Infected Adolescents
A study testing Structured treatment interruption in people with HIV Infections, run by University of North Carolina, Chapel Hill at 4 sites in United States.
Trial summary
This study will attempt to stimulate the immune system in HIV infected adolescents and young adults so that it can better control the HIV infection. When anti-HIV drugs are stopped for a period of time, the virus "grows back." This may stimulate the immune system, which may then be more effective in controlling the… Read more about this study
- Who is it for?
- Ages 14 to 21 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Structured treatment interruption
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2003to 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 14 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Acquired HIV infection after age 12 years
- CD4 cell count greater than 500 cells/microL within 30 days of study entry
- Either on HAART for 3 to 6 months with HIV-1 RNA < 400 copies/ml or on HAART for more than 2 years with at least one HIV-1 RNA < 400 copies/ml each six month period
- HAART regimen of two NRTIs and at least one PI (not nelfinavir)
- HIV-1 RNA 5,000 copies/ml prior to HAART and documented CD4 cell values
- CMV positive
- Ability and willingness of subject (and parent/guardian where required) to give informed consent
Who cannot join
- Started initial HAART regimen less than one year after known HIV-1 seroconversion
- Immunosuppressive therapy
- Certain medications
- Pregnancy
- Evidence of an opportunistic infection
- Laboratory values that are classified as Grade 3 or higher toxicities at the time of study enrollment
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Children's Diagnostic and Treatment Center
Fort Lauderdale, Florida
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania
University of California at San Diego
San Diego, California
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Structured Treatment Interruption as an Autovaccination Approach to Enhance Immune Based HIV-1 Control in an Adolescent/Young Adult Population
This study will attempt to stimulate the immune system in HIV infected adolescents and young adults so that it can better control the HIV infection. When anti-HIV drugs are stopped for a period of time, the virus "grows back." This may stimulate the immune system, which may then be more effective in controlling the virus.
Read the detailed description
The focus of this study is to use Structured Treatment Interruption (STI) as an approach to auto-immunization. The STI management schema is based on current understanding of HIV-1 viral dynamics, pharmacology of available antiretroviral medications, and HIV-specific host responses. This is a Phase II trial to provide preliminary data on the feasibility and possible efficacy of using STI to enhance immune-based control of HIV-1 replication. A steady state HIV-1 viral load determined from historical tests prior to initiating highly active antiretroviral therapy (HAART) will be compared to the steady state viral load post-STI. HIV-1 specific CD4 and CD8 cell responses will be measured before and after the period of STI management and HIV-1 specific CD8 cell maturational phenotype will be assessed and correlated with ability to control viral replication.
Adolescents and young adults who have either had sustained viral suppression on HAART for at least 2 years or who have had sustained viral suppression from 3 to 6 months will be eligible for this study. Participants will have 12 weeks of HAART followed by 2 to 4 weeks of treatment interruption. Participants will undergo three rounds of this regimen. After the third STI, participants will have an additional 12 weeks of HAART and then stop therapy. Participants will be monitored off HAART for up to 20 weeks. During this time, if there is evidence of HIV progression (two consecutive viral loads exceeding 10,000 copies/ml; two consecutive CD4 cell counts under 350 cells/microL; two consecutive CD4 percentages less than 15%; or two consecutive CD4 cell counts less than 50% of baseline), standard continuous antiretroviral therapy will be reinstituted. Plasma HIV RNA will be tested monthly during therapy and weekly while subjects are off treatment. Immunologic studies are monthly throughout the study. Participants will be involved in the study for approximately 2 years.
- Conditions
- HIV Infections
- Being tested
- Structured treatment interruption
- Keywords
- Structured treatment interruption, Treatment experienced
- 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2003 (estimated)
- Study startJul 2003
Why it stopped: The study was never opened for enrollment; concept became irrelevant as other study results became available.
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 University of North Carolina, Chapel HillThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Craig M Wilson, MD, Study chair, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00067574
- Sponsor's protocol ID
- ATN 008
- Status last verified
- Jul 2016
- First submitted
- 25 Aug 2003
- Last updated
- 6 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structured Treatment Interruption as an Autovaccination Approach to Enhance Immune Based HIV-1 Control in an Adolescent/Young Adult Population
- ClinicalTrials.gov ID
- NCT00067574
- Acronym / sponsor ID
- ATN 008
- Conditions
- HIV Infections
- Keywords
- Structured treatment interruption, Treatment experienced
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was never opened for enrollment; concept became irrelevant as other study results became available.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Jul 2003
- First posted
- 26 Aug 2003 (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 attempt to stimulate the immune system in HIV infected adolescents and young adults so that it can better control the HIV infection. When anti-HIV drugs are stopped for a period of time, the virus "grows back." This may stimulate the immune system, which may then be more effective in controlling the virus.
Detailed description
The focus of this study is to use Structured Treatment Interruption (STI) as an approach to auto-immunization. The STI management schema is based on current understanding of HIV-1 viral dynamics, pharmacology of available antiretroviral medications, and HIV-specific host responses. This is a Phase II trial to provide preliminary data on the feasibility and possible efficacy of using STI to enhance immune-based control of HIV-1 replication. A steady state HIV-1 viral load determined from historical tests prior to initiating highly active antiretroviral therapy (HAART) will be compared to the steady state viral load post-STI. HIV-1 specific CD4 and CD8 cell responses will be measured before and after the period of STI management and HIV-1 specific CD8 cell maturational phenotype will be assessed and correlated with ability to control viral replication.
Adolescents and young adults who have either had sustained viral suppression on HAART for at least 2 years or who have had sustained viral suppression from 3 to 6 months will be eligible for this study. Participants will have 12 weeks of HAART followed by 2 to 4 weeks of treatment interruption. Participants will undergo three rounds of this regimen. After the third STI, participants will have an additional 12 weeks of HAART and then stop therapy. Participants will be monitored off HAART for up to 20 weeks. During this time, if there is evidence of HIV progression (two consecutive viral loads exceeding 10,000 copies/ml; two consecutive CD4 cell counts under 350 cells/microL; two consecutive CD4 percentages less than 15%; or two consecutive CD4 cell counts less than 50% of baseline), standard continuous antiretroviral therapy will be reinstituted. Plasma HIV RNA will be tested monthly during therapy and weekly while subjects are off treatment. Immunologic studies are monthly throughout the study. Participants will be involved in the study for approximately 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 14 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Acquired HIV infection after age 12 years
- CD4 cell count greater than 500 cells/microL within 30 days of study entry
- Either on HAART for 3 to 6 months with HIV-1 RNA < 400 copies/ml or on HAART for more than 2 years with at least one HIV-1 RNA < 400 copies/ml each six month period
- HAART regimen of two NRTIs and at least one PI (not nelfinavir)
- HIV-1 RNA 5,000 copies/ml prior to HAART and documented CD4 cell values
Key exclusion criteria (6 listed)
- Started initial HAART regimen less than one year after known HIV-1 seroconversion
- Immunosuppressive therapy
- Certain medications
- Pregnancy
- Evidence of an opportunistic infection
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 interruption | Behavioural | – |
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 6 Mar 2017.
- Description of Adolescent Trials Networks (ATN) and contact informationLink 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.
Craig M Wilson, MD study chair
University of Alabama at Birmingham
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured treatment interruption in people with HIV Infections, run by University of North Carolina, Chapel Hill at 4 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 6 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 6 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 6 Mar 2017.