HIV InfectionsPhase 4NCT00068809
4-Day-A-Week Treatment Plan for HIV Infected Adolescents
A Phase 4 study testing Short Cycle Antiretroviral Therapy in people with HIV Infections, run by University of North Carolina, Chapel Hill at 9 sites in 2 countries.
Trial summary
This study will determine if taking anti-HIV drugs 4 days a week will control HIV-1 viral replication in patients who have already had at least 6 months of documented viral suppression with full-time treatment. Read more about this study
- Who is it for?
- Ages 12 to 24 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Short Cycle Antiretroviral Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Jul 2003to Jan 2007
- Phase
- Phase 4
- 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 12 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Twelve to 24 years of age, regardless of the mode of transmission.
- Subjects must have been on a stable HAART regimen containing at least one PI and two NRTIs and no NNRTI for at least 3 months and be willing to continue the PI-containing regimen throughout the study period.
- Acceptable viral load defined as at least three plasma HIV-1 RNA levels ≤ 400 copies/ml within 12 months of study entry and no plasma HIV-1 RNA levels > 400 copies/ml within 6 months of entry date employing any clinically available viral load assay.
- Pre entry plasma HIV-1 RNA level <200 copies/ml by ultra-sensitive assay (Roche 1.5) within 30 days of study entry, performed in an assigned PACTG core virology laboratory.
- CD4+ T cell count >350 cells/microL within 30 days of study entry.
- Ability of subject and parent or legal guardian (when appropriate) to give written informed assent/consent and permission respectively.
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- Subjects currently enrolled in ATN 015 Version 2.0 are eligible as follows:
- Subjects randomized to standard continuous therapy (control arm). These subjects are eligible to be enrolled in ATN 015 Version 3.0 as new subjects if they meet the entry criteria for ATN Version 3.0. If eligible, they will be followed for the full 48 weeks.
- Subjects randomized to short cycle therapy (experimental arm). These subjects are eligible to rollover to ATN 015 Version 3.0 and continue on SCT if they have not met a study endpoint. These subjects may not have a viral load value that meets a study endpoint (viz. a confirmed viral load of >400 copies/ml) and will continue on the intensive monitoring until they have completed 24 weeks when they will enter the less intensive 24 week phase of the study.
- Female subjects must be non-pregnant and willing to remain on effective contraception for the duration of the study. (Examples of acceptable forms of birth control include but are not limited to any form of hormonal contraception along with a barrier method, double barrier method, tubal ligation, or abstinence if it is the choice of the subject.)
Who cannot join
- On a HAART regimen containing an NNRTI or a HAART regimen with Abacavir (including Trizivir®).
- On any prohibited medication at the time of screening. Subjects with underlying reactive airway disease who are on either inhaled or brief, intermittent systemic steroids can be considered but their status must be reviewed with the protocol chair or vice chair through the standard ATN protocol query process.
- Active HIV-related opportunistic infection or any malignancy at the time of screening. (Female subjects who have been treated adequately for cervical dysplasia or CIN are eligible for study unless they are on systemic immunosuppressive therapy).
- Current treatment for known or suspected active serious bacterial infection.
- Pregnancy.
- Any laboratory abnormalities Grade 3 or greater as defined in Appendix III at the time of screening.
- Subjects receiving pharmacological treatment for elevated cholesterol and triglyceride levels.
- If a candidate fails the eligibility criteria (inclusion or exclusion), she or he may be screened again for eligibility after a period of 30 days.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States8 sites
Stoger Hospital of Cook County
Chicago, Illinois, 60612
Children's Diagnostic and Treatment Center
Fort Lauderdale, Florida, 33316
Children's Hopsital of Los Angeles
Los Angeles, California, 90027
University of Miami
Miami, Florida, 33101
Mt. Sinai Hospital
New York, New York, 01129
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of California at San Diego
San Diego, California, 92102
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Short-Cycle Therapy in Adolescents Following Continuous Therapy With Established Viral Suppression: The Impact on Viral Load Suppression
This study will determine if taking anti-HIV drugs 4 days a week will control HIV-1 viral replication in patients who have already had at least 6 months of documented viral suppression with full-time treatment. If this strategy is shown to be safe in this study, a larger study will be undertaken to determine if the strategy can decrease overall drug exposure and help young people adjust more easily to a chronic medication schedule.
Read the detailed description
HIV infected adolescents who require therapy face a lifetime of antiretroviral treatment. Highly active antiretroviral therapy (HAART) is associated with short- and long-term complications, and concerns are mounting about the cumulative effect of these complications as adolescents enter the third and fourth decade of life. A management strategy that can suppress the virus and decrease overall drug exposure is needed. In addition, the scheduling requirements for antiretroviral therapies interfere with the socialization and independence that an adolescent must accomplish to gain skills for a successful adult life. Not surprisingly, nonadherence to prescribed medications is common in teens. This multicenter, prospective, proof of concept trial will evaluate Short Cycle Therapy (SCT) in adolescents with sustained viral suppression of at least 6 months. While maintenance of viral load suppression can be viewed as either a safety or efficacy endpoint, the trial is constructed as an assessment of safety.
Eligible participants who have been on standard HAART therapy consisting of a Protease Inhibitor will switch to SCT therapy(4 days on treatment, 3 days off treatment each week) at entry. Participants will be seen in the clinic every other Monday during the first month, then monthly up to 24-weeks and then once every two months until the end of the 48-week study period. Plasma HIV RNA levels and CD4 cell counts will be performed at every visit. Medication adherence by self-report will be conducted every 2 weeks until week 24 and every 4-weeks thereafter until week 48. Fasting serum triglycerides and cholesterol will be measured at baseline, at week 24 and at the end of the study.
- Conditions
- HIV Infections
- Being tested
- Short Cycle Antiretroviral Therapy
- Keywords
- Treatment experienced, Treatment interruption
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short Cycle Antiretroviral TherapyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Short-cycle therapy (SCT) | Experimental | At entry, subjects will switch from continuous HAART to SCT. All subjects will then be followed to assess viral load breakthrough over 48 weeks on SCT. Receives: Procedure: Short Cycle Antiretroviral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess VL Suppression for Subjects on SCT over a 24 Week and 48 Week Period
To assess viral load suppression (≤ 400 copies/ml) for subjects on SCT over a 24 week and a 48 week period.
The primary endpoint is defined as the time of confirmed VL > 400 copies/ml at any time after study entry up to and including the 48th week of follow-up.
Measured: 48 Weeks
Secondary outcomes (4)
Assess CD4+ T-cell count over time for subjects on SCT from baseline to week 48
To assess CD4+ T-cell count over time for subjects on SCT from baseline to week 48. These values will be compared at (1) the period of time from study entry to viral load rebound (> 400 copies/ml), (2) the period of time from study entry to subject dropout, or (3) the period of time from study entry to administrative end of study at 48 weeks, depending on each subject's disposition.
Measured: 48 Weeks
Compare differences in various values from study entry to Weeks 24 and 48
To compare differences in fasting cholesterol, triglycerides, LDL, HDL, and VLDL levels from study entry to weeks 24 and 48
Measured: 48 Weeks
Assess the adherence level over time
To assess the adherence level over time using the PACTG Pediatric Adherence Questionnaire Module I, every two weeks up to week 24 and every four weeks until week 48
Measured: Week 48
Assess genotypic resistance as necessary
To assess subject-specific plasma genotypic resistance for subjects with viral load >1000 copies/ml at time of viral load rebound.
Measured: 48 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2003 (estimated)
- Study startJul 2003
- Primary completionJan 2007
- Study completionJan 2007
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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 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
- Bret J Rudy, MD, Study chair, Children's Hospital of Philadelphia, The University of Pennsylvania School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00068809
- Sponsor's protocol ID
- ATN 015 v 3.0
- Status last verified
- Feb 2016
- First submitted
- 10 Sep 2003
- Last updated
- 1 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Cycle Therapy in Adolescents Following Continuous Therapy With Established Viral Suppression: The Impact on Viral Load Suppression
- ClinicalTrials.gov ID
- NCT00068809
- Acronym / sponsor ID
- ATN 015 v 3.0
- Conditions
- HIV Infections
- Keywords
- Treatment experienced, Treatment interruption
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 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
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 11 Sep 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 determine if taking anti-HIV drugs 4 days a week will control HIV-1 viral replication in patients who have already had at least 6 months of documented viral suppression with full-time treatment. If this strategy is shown to be safe in this study, a larger study will be undertaken to determine if the strategy can decrease overall drug exposure and help young people adjust more easily to a chronic medication schedule.
Detailed description
HIV infected adolescents who require therapy face a lifetime of antiretroviral treatment. Highly active antiretroviral therapy (HAART) is associated with short- and long-term complications, and concerns are mounting about the cumulative effect of these complications as adolescents enter the third and fourth decade of life. A management strategy that can suppress the virus and decrease overall drug exposure is needed. In addition, the scheduling requirements for antiretroviral therapies interfere with the socialization and independence that an adolescent must accomplish to gain skills for a successful adult life. Not surprisingly, nonadherence to prescribed medications is common in teens. This multicenter, prospective, proof of concept trial will evaluate Short Cycle Therapy (SCT) in adolescents with sustained viral suppression of at least 6 months. While maintenance of viral load suppression can be viewed as either a safety or efficacy endpoint, the trial is constructed as an assessment of safety.
Eligible participants who have been on standard HAART therapy consisting of a Protease Inhibitor will switch to SCT therapy(4 days on treatment, 3 days off treatment each week) at entry. Participants will be seen in the clinic every other Monday during the first month, then monthly up to 24-weeks and then once every two months until the end of the 48-week study period. Plasma HIV RNA levels and CD4 cell counts will be performed at every visit. Medication adherence by self-report will be conducted every 2 weeks until week 24 and every 4-weeks thereafter until week 48. Fasting serum triglycerides and cholesterol will be measured at baseline, at week 24 and at the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Short-cycle therapy (SCT) | Experimental | Procedure: Short Cycle Antiretroviral TherapyAt entry, subjects will switch from continuous HAART to SCT. All subjects will then be followed to assess viral load breakthrough over 48 weeks on SCT. |
Who may qualify
- Ages
- 12 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Twelve to 24 years of age, regardless of the mode of transmission.
- Subjects must have been on a stable HAART regimen containing at least one PI and two NRTIs and no NNRTI for at least 3 months and be willing to continue the PI-containing regimen throughout the study period.
- Acceptable viral load defined as at least three plasma HIV-1 RNA levels ≤ 400 copies/ml within 12 months of study entry and no plasma HIV-1 RNA levels > 400 copies/ml within 6 months of entry date employing any clinically available viral load assay.
- Pre entry plasma HIV-1 RNA level <200 copies/ml by ultra-sensitive assay (Roche 1.5) within 30 days of study entry, performed in an assigned PACTG core virology laboratory.
- CD4+ T cell count >350 cells/microL within 30 days of study entry.
Key exclusion criteria (8 listed)
- On a HAART regimen containing an NNRTI or a HAART regimen with Abacavir (including Trizivir®).
- On any prohibited medication at the time of screening. Subjects with underlying reactive airway disease who are on either inhaled or brief, intermittent systemic steroids can be considered but their status must be reviewed with the protocol chair or vice chair through the standard ATN protocol query process.
- Active HIV-related opportunistic infection or any malignancy at the time of screening. (Female subjects who have been treated adequately for cervical dysplasia or CIN are eligible for study unless they are on systemic immunosuppressive therapy).
- Current treatment for known or suspected active serious bacterial infection.
- Pregnancy.
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 |
|---|---|---|
| Short Cycle Antiretroviral Therapy | Procedure or surgery | Short-cycle therapy (SCT) |
Primary outcome
Assess VL Suppression for Subjects on SCT over a 24 Week and 48 Week Period
Time frame: 48 Weeks
To assess viral load suppression (≤ 400 copies/ml) for subjects on SCT over a 24 week and a 48 week period. The primary endpoint is defined as the time of confirmed VL > 400 copies/ml at any time after study entry up to and including the 48th week of follow-up.
4 secondary outcomes
Assess CD4+ T-cell count over time for subjects on SCT from baseline to week 48
Time frame: 48 Weeks
Compare differences in various values from study entry to Weeks 24 and 48
Time frame: 48 Weeks
Assess the adherence level over time
Time frame: Week 48
Assess genotypic resistance as necessary
Time frame: 48 Weeks
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 1 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.
Bret J Rudy, MD study chair
Children's Hospital of Philadelphia, The University of Pennsylvania School of Medicine
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Short Cycle Antiretroviral Therapy in people with HIV Infections, run by University of North Carolina, Chapel Hill at 9 sites in 2 countries.
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 10 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 1 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 9 sites in United States, Puerto Rico. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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.
What does the primary outcome measure?
Assess VL Suppression for Subjects on SCT over a 24 Week and 48 Week Period (time frame: 48 Weeks). It is what the study was designed to measure, not a finding.
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 1 Mar 2017; AzTrials last refreshed its copy on 7 Nov 2026.