HIV InfectionsPhase 3NCT00075907
Anti-HIV Drug Regimens With or Without Protease Inhibitors and Drug Level Monitoring in HIV Infected Adolescents
A Phase 3 study testing Efavirenz + 2 NRTIs, Lopinavir/Ritonavir + 2 NRTIs and Therapeutic Drug Monitoring in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 13 sites in United States.
Trial summary
The purpose of this study is to compare the effectiveness of anti-HIV drug regimens with or without a protease inhibitor (PI) in HIV infected adolescents. It will also determine if monitoring drug levels and adjusting the dose as necessary improves the effectiveness of these regimens. Read more about this study
- Who is it for?
- Ages 13 to 23 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Efavirenz + 2 NRTIs, Lopinavir/Ritonavir + 2 NRTIs and Therapeutic Drug Monitoring
- Type of treatment
- Surgery or procedure
- How many people
- 240 participants
- Where
- 13 sitesUnited States
- Study dates
- Jul 2004to Sep 2006
- Phase
- Phase 3
- 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 13 to 23 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- HIV infected
- HIV RNA viral load of 10,000 copies/ml or more at screening
- Weigh 35 kg (77.2 lbs) or more
- HAART naive or received a single regimen of combination therapy consisting of NRTIs with or without a single PI (except LPV). Patients who received zidovudine monotherapy during pregnancy or used low-dose ritonavir (RTV) as a PI boost are not excluded.
- For PI experienced patients, have sensitivity to LPV at screening
- Able to receive, as part of background HAART chosen by their physician, at least one new NRTI that is likely to be active against the patient's virus and unlikely to have cross-resistance with previously used NRTIs
- Willing to use acceptable forms of contraception
- Parent or legal guardian willing to provide informed consent, if applicable
Who cannot join
- Prior receipt of any NNRTI or LPV
- Require certain medications
- Grade 3 or 4 clinical or laboratory toxicity, as defined by the Division of AIDS Toxicity Table for Grading Severity of Pediatric Adverse Effects
- Chemotherapy for active malignancy
- Acute opportunistic or serious bacterial infection requiring therapy at study entry
- Investigational treatment within 30 days of study entry
Show all 9Show fewer
- Score of 20 or more on Beck Depression Inventory (BDI-II) or suicidal thoughts on BDI-II (score of 2 or 3 on Question 9), regardless of total score
- Pregnant within 48 hours of starting EFV
- Breastfeeding
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Usc La Nichd Crs
Alhambra, California, 91803
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, 80045
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
Baltimore, Maryland, 21287
Chicago Children's CRS
Chicago, Illinois, 60614
Children's Med. Ctr. Dallas
Dallas, Texas, 75235
Texas Children's Hosp. CRS
Houston, Texas, 77030
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, 90806
Children's Hospital of Los Angeles NICHD CRS
Los Angeles, California, 90027
St. Jude/UTHSC CRS
Memphis, Tennessee, 38105
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana, 70112
Children's Hosp.
New Orleans, Louisiana, 70118
SUNY Stony Brook NICHD CRS
Stony Brook, New York, 11794
Bronx-Lebanon Hosp. IMPAACT CRS
The Bronx, New York, 10457
About this study
Official title: A Comparative Trial of Protease-Containing and Protease-Sparing HAART Regimens in HIV-Infected Adolescents With an Evaluation of Therapeutic Drug Monitoring
The purpose of this study is to compare the effectiveness of anti-HIV drug regimens with or without a protease inhibitor (PI) in HIV infected adolescents. It will also determine if monitoring drug levels and adjusting the dose as necessary improves the effectiveness of these regimens.
Read the detailed description
HIV infected adolescents may have a significantly higher capacity for immune reconstitution following highly active antiretroviral therapy (HAART), compared to adults. Despite this advantage, HIV infected adolescents are often reluctant to get proper medical care, follow through with doctor appointments, and adhere to medication schedules and regimens necessary to keep their infection under control. Lopinavir/ritonavir (LPV/r), a PI, and efavirenz (EFV), a non-nucleoside reverse transcriptase inhibitor (NNRTI), both have long half-lives that make them ideal drugs for the adolescent population, as they are more forgiving if patients miss or sleep through doses. The availability of once-daily dosing of LPV/r will reduce pill burden and offers more flexibility in medication scheduling, also helping to promote treatment adherence among this age group. This study will examine the effectiveness of two HAART regimens, one with the PI LPV/r and two nucleoside reverse transcriptase inhibitors (NRTIs), and the other with the NNRTI EFV and two NRTIs. The efficacy of therapeutic drug monitoring (TDM) and subsequent dose adjustment will also be assessed with both regimens.
Patients will be enrolled in this study for 96 weeks and will be randomly assigned into one of two groups. Group 1 will receive LPV/r and 2 NRTIs. Treatment naive patients in Group 1 will have the option of receiving either once-daily dosing or twice-daily dosing of LPV/r. Treatment experienced patients will receive twice-daily dosing of LPV/r. Patients on once-daily dosing of LPV/r who become intolerant to the regimen will be permitted to switch to twice-daily dosing. Group 2 will receive EFV and 2 NRTIs. All patients will be independently and simultaneously randomly assigned to undergo either TDM with subsequent dose adjustment if necessary or no TDM.
Patient medical history and physical exam will be conducted at screening, entry, Weeks 2, 4, 8, every 8 weeks until Week 48, and every 12 weeks thereafter. Blood collection will occur at all study visits. Self-reported pill counts and MEMS TrackCap readings (on LPV/r and EFV bottles) will be noted at most visits. Patients will be asked to complete adherence questionnaires at selected study visits.
Patients enrolled in PACTG 390 (Different Combination Regimens and Treatment-Switching Guidelines in HIV Infected Children 18 Years of Age and Younger) are encouraged to coenroll simultaneously in this study and in PACTG 219C (Long-Term Effects of HIV Exposure and Infection in Children).
- Conditions
- HIV Infections
- Being tested
- Efavirenz + 2 NRTIs, Lopinavir/Ritonavir + 2 NRTIs, Therapeutic Drug Monitoring
- Keywords
- Acute Infection, Treatment Experienced, Treatment Naive
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efavirenz + 2 NRTIsDrug
Lopinavir/Ritonavir + 2 NRTIsDrug
Therapeutic Drug MonitoringProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving viral suppression (viral load less than 1,000 copies/ml) at Week 24 and maintaining suppression through Week 48 while remaining on study treatment
Secondary outcomes (11)
Proportion of patients achieving virologic suppression (viral load less than 1,000 copies/ml) at Week 24 and maintaining suppression through Week 96 while remaining on study treatment
adherence measured by MEMS TrackCap Monitors (percentage of doses taken, estimated using the frequency of bottle openings recorded by the MEMS TrackCap Monitors, the MEMS TrackCap Monitor tracking form, and the information recorded on the questionnaires)
adherence measured by patient self-report (binary variable of perfect adherence measured 3 days prior to any study visit reported on the adherence questionnaires and the numbers of visits with reported perfect adherence up to Week 24, 48, and 96)
adherence measured by pill count (percentage of pills taken, determined by counting the pills left in the bottles)
HIV viral load at each study visit
number and severity of symptoms of distress and central nervous system (CNS) side effects
number and severity of all adverse events of Grade 3 or more attributed to study treatment
time to virologic failure (first time viral load is measured to be 1,000 copies/ml or more after Week 24, time before discontinuing study treatment for any reason before Week 96, or time before terminating study for any reason before Week 96)
HIV resistance mutations at baseline and at time of virologic failure (viral load returning to 1,000 copies/ml or more)
baseline values for percentage and total number of CD19 (B cells), total T cells (CD3 T cells), CD4 (T helper cells), CD8 (cytotoxic T cells), naive CD4 T cells (CD62L/CD45RA/CD4), and activated CD8 T cells (HLADR/CD38/CD8)
changes from baseline to Weeks 24, 48, and 96 for percentage and total number of CD19 (B cells), total T cells (CD3 T cells), CD4 (T helper cells), CD8 (cytotoxic T cells), naive CD4 T cells (CD62L/CD45RA/CD4), and activated CD8 T cells (HLADR/CD38/CD8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2004 (estimated)
- Study startJul 2004
- Study completionSep 2006
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Margarita Silio, MD, Study chair, Tulane Medical CenterRussell Van Dyke, MD, Study chair, Tulane Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00075907
- Sponsor's protocol ID
- PACTG P1034
- Other IDs
- DAIDS-ES ID 10043
- Status last verified
- Oct 2013
- First submitted
- 9 Jan 2004
- Last updated
- 7 Oct 2013
- Results posted
- No
Publications
Eron JJ, Feinberg J, Kessler HA, Horowitz HW, Witt MD, Carpio FF, Wheeler DA, Ruane P, Mildvan D, Yangco BG, Bertz R, Bernstein B, King MS, Sun E. Once-daily versus twice-daily lopinavir/ritonavir in antiretroviral-naive HIV-positive patients: a 48-week randomized clinical trial. J Infect Dis. 2004 Jan 15;189(2):265-72. doi: 10.1086/380799. Epub 2004 Jan 7.
PubMed 14722892Deschamps AE, Graeve VD, van Wijngaerden E, De Saar V, Vandamme AM, van Vaerenbergh K, Ceunen H, Bobbaers H, Peetermans WE, de Vleeschouwer PJ, de Geest S. Prevalence and correlates of nonadherence to antiretroviral therapy in a population of HIV patients using Medication Event Monitoring System. AIDS Patient Care STDS. 2004 Nov;18(11):644-57. doi: 10.1089/apc.2004.18.644.
PubMed 15633262Murphy DA, Sarr M, Durako SJ, Moscicki AB, Wilson CM, Muenz LR; Adolescent Medicine HIV/AIDS Research Network. Barriers to HAART adherence among human immunodeficiency virus-infected adolescents. Arch Pediatr Adolesc Med. 2003 Mar;157(3):249-55. doi: 10.1001/archpedi.157.3.249.
PubMed 12622674Paterson DL, Swindells S, Mohr J, Brester M, Vergis EN, Squier C, Wagener MM, Singh N. Adherence to protease inhibitor therapy and outcomes in patients with HIV infection. Ann Intern Med. 2000 Jul 4;133(1):21-30. doi: 10.7326/0003-4819-133-1-200007040-00004.
PubMed 10877736Van Dyke RB, Lee S, Johnson GM, Wiznia A, Mohan K, Stanley K, Morse EV, Krogstad PA, Nachman S; Pediatric AIDS Clinical Trials Group Adherence Subcommittee Pediatric AIDS Clinical Trials Group 377 Study Team. Reported adherence as a determinant of response to highly active antiretroviral therapy in children who have human immunodeficiency virus infection. Pediatrics. 2002 Apr;109(4):e61. doi: 10.1542/peds.109.4.e61.
PubMed 11927734
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Trial of Protease-Containing and Protease-Sparing HAART Regimens in HIV-Infected Adolescents With an Evaluation of Therapeutic Drug Monitoring
- ClinicalTrials.gov ID
- NCT00075907
- Acronym / sponsor ID
- PACTG P1034
- Conditions
- HIV Infections
- Keywords
- Acute Infection, Treatment Experienced, Treatment Naive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jul 2004
- Study completion
- Sep 2006 (actual)
- First posted
- 13 Jan 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.
The purpose of this study is to compare the effectiveness of anti-HIV drug regimens with or without a protease inhibitor (PI) in HIV infected adolescents. It will also determine if monitoring drug levels and adjusting the dose as necessary improves the effectiveness of these regimens.
Detailed description
HIV infected adolescents may have a significantly higher capacity for immune reconstitution following highly active antiretroviral therapy (HAART), compared to adults. Despite this advantage, HIV infected adolescents are often reluctant to get proper medical care, follow through with doctor appointments, and adhere to medication schedules and regimens necessary to keep their infection under control. Lopinavir/ritonavir (LPV/r), a PI, and efavirenz (EFV), a non-nucleoside reverse transcriptase inhibitor (NNRTI), both have long half-lives that make them ideal drugs for the adolescent population, as they are more forgiving if patients miss or sleep through doses. The availability of once-daily dosing of LPV/r will reduce pill burden and offers more flexibility in medication scheduling, also helping to promote treatment adherence among this age group. This study will examine the effectiveness of two HAART regimens, one with the PI LPV/r and two nucleoside reverse transcriptase inhibitors (NRTIs), and the other with the NNRTI EFV and two NRTIs. The efficacy of therapeutic drug monitoring (TDM) and subsequent dose adjustment will also be assessed with both regimens.
Patients will be enrolled in this study for 96 weeks and will be randomly assigned into one of two groups. Group 1 will receive LPV/r and 2 NRTIs. Treatment naive patients in Group 1 will have the option of receiving either once-daily dosing or twice-daily dosing of LPV/r. Treatment experienced patients will receive twice-daily dosing of LPV/r. Patients on once-daily dosing of LPV/r who become intolerant to the regimen will be permitted to switch to twice-daily dosing. Group 2 will receive EFV and 2 NRTIs. All patients will be independently and simultaneously randomly assigned to undergo either TDM with subsequent dose adjustment if necessary or no TDM.
Patient medical history and physical exam will be conducted at screening, entry, Weeks 2, 4, 8, every 8 weeks until Week 48, and every 12 weeks thereafter. Blood collection will occur at all study visits. Self-reported pill counts and MEMS TrackCap readings (on LPV/r and EFV bottles) will be noted at most visits. Patients will be asked to complete adherence questionnaires at selected study visits.
Patients enrolled in PACTG 390 (Different Combination Regimens and Treatment-Switching Guidelines in HIV Infected Children 18 Years of Age and Younger) are encouraged to coenroll simultaneously in this study and in PACTG 219C (Long-Term Effects of HIV Exposure and Infection in Children).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 13 to 23 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- HIV infected
- HIV RNA viral load of 10,000 copies/ml or more at screening
- Weigh 35 kg (77.2 lbs) or more
- HAART naive or received a single regimen of combination therapy consisting of NRTIs with or without a single PI (except LPV). Patients who received zidovudine monotherapy during pregnancy or used low-dose ritonavir (RTV) as a PI boost are not excluded.
- For PI experienced patients, have sensitivity to LPV at screening
Key exclusion criteria (9 listed)
- Prior receipt of any NNRTI or LPV
- Require certain medications
- Grade 3 or 4 clinical or laboratory toxicity, as defined by the Division of AIDS Toxicity Table for Grading Severity of Pediatric Adverse Effects
- Chemotherapy for active malignancy
- Acute opportunistic or serious bacterial infection requiring therapy at study entry
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 |
|---|---|---|
| Efavirenz + 2 NRTIs | Drug | – |
| Lopinavir/Ritonavir + 2 NRTIs | Drug | – |
| Therapeutic Drug Monitoring | Procedure or surgery | – |
Primary outcome
Proportion of patients achieving viral suppression (viral load less than 1,000 copies/ml) at Week 24 and maintaining suppression through Week 48 while remaining on study treatment
11 secondary outcomes
Proportion of patients achieving virologic suppression (viral load less than 1,000 copies/ml) at Week 24 and maintaining suppression through Week 96 while remaining on study treatment
adherence measured by MEMS TrackCap Monitors (percentage of doses taken, estimated using the frequency of bottle openings recorded by the MEMS TrackCap Monitors, the MEMS TrackCap Monitor tracking form, and the information recorded on the questionnaires)
adherence measured by patient self-report (binary variable of perfect adherence measured 3 days prior to any study visit reported on the adherence questionnaires and the numbers of visits with reported perfect adherence up to Week 24, 48, and 96)
adherence measured by pill count (percentage of pills taken, determined by counting the pills left in the bottles)
HIV viral load at each study visit
number and severity of symptoms of distress and central nervous system (CNS) side effects
number and severity of all adverse events of Grade 3 or more attributed to study treatment
time to virologic failure (first time viral load is measured to be 1,000 copies/ml or more after Week 24, time before discontinuing study treatment for any reason before Week 96, or time before terminating study for any reason before Week 96)
HIV resistance mutations at baseline and at time of virologic failure (viral load returning to 1,000 copies/ml or more)
baseline values for percentage and total number of CD19 (B cells), total T cells (CD3 T cells), CD4 (T helper cells), CD8 (cytotoxic T cells), naive CD4 T cells (CD62L/CD45RA/CD4), and activated CD8 T cells (HLADR/CD38/CD8)
changes from baseline to Weeks 24, 48, and 96 for percentage and total number of CD19 (B cells), total T cells (CD3 T cells), CD4 (T helper cells), CD8 (cytotoxic T cells), naive CD4 T cells (CD62L/CD45RA/CD4), and activated CD8 T cells (HLADR/CD38/CD8)
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 7 Oct 2013.
- Background: PubMed 14722892Eron JJ, Feinberg J, Kessler HA, Horowitz HW, Witt MD, Carpio FF, Wheeler DA, Ruane P, Mildvan D, Yangco BG, Bertz R, Bernstein B, King MS, Sun E. Once-daily versus twice-daily lopinavir/ritonavir in antiretroviral-naive HIV-positive patients: a 48-week randomized clinical trial. J Infect Dis. 2004 Jan 15;189(2):265-72. doi: 10.1086/380799. Epub 2004 Jan 7.
- Background: PubMed 15633262Deschamps AE, Graeve VD, van Wijngaerden E, De Saar V, Vandamme AM, van Vaerenbergh K, Ceunen H, Bobbaers H, Peetermans WE, de Vleeschouwer PJ, de Geest S. Prevalence and correlates of nonadherence to antiretroviral therapy in a population of HIV patients using Medication Event Monitoring System. AIDS Patient Care STDS. 2004 Nov;18(11):644-57. doi: 10.1089/apc.2004.18.644.
- Background: PubMed 12622674Murphy DA, Sarr M, Durako SJ, Moscicki AB, Wilson CM, Muenz LR; Adolescent Medicine HIV/AIDS Research Network. Barriers to HAART adherence among human immunodeficiency virus-infected adolescents. Arch Pediatr Adolesc Med. 2003 Mar;157(3):249-55. doi: 10.1001/archpedi.157.3.249.
- Background: PubMed 10877736Paterson DL, Swindells S, Mohr J, Brester M, Vergis EN, Squier C, Wagener MM, Singh N. Adherence to protease inhibitor therapy and outcomes in patients with HIV infection. Ann Intern Med. 2000 Jul 4;133(1):21-30. doi: 10.7326/0003-4819-133-1-200007040-00004.
- Background: PubMed 11927734Van Dyke RB, Lee S, Johnson GM, Wiznia A, Mohan K, Stanley K, Morse EV, Krogstad PA, Nachman S; Pediatric AIDS Clinical Trials Group Adherence Subcommittee Pediatric AIDS Clinical Trials Group 377 Study Team. Reported adherence as a determinant of response to highly active antiretroviral therapy in children who have human immunodeficiency virus infection. Pediatrics. 2002 Apr;109(4):e61. doi: 10.1542/peds.109.4.e61.
- Click here for more information about PACTG 390Link provided by the sponsor.
- Click here for more information about PACTG 219CLink 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.
Margarita Silio, MD study chair
Tulane Medical Center
Russell Van Dyke, MD study chair
Tulane Medical Center
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Efavirenz + 2 NRTIs, Lopinavir/Ritonavir + 2 NRTIs and Therapeutic Drug Monitoring in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 13 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 8 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 7 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Proportion of patients achieving viral suppression (viral load less than 1,000 copies/ml) at Week 24 and maintaining suppression through Week 48 while remaining on study treatment. 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 NCT00075907, 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 7 Oct 2013.