HIV InfectionsPhase 3NCT00041769
Using Drug Levels in the Blood to Guide Therapy in HIV Infected Patients Taking a Protease Inhibitor
A Phase 3 study testing Therapeutic Drug Monitoring (TDM) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 47 sites in 2 countries.
Trial summary
Drug resistance testing can be used to see which anti-HIV drugs are likely to suppress the growth of HIV and to select an anti-HIV regimen for HIV infected patients who have failed previous drug regimens. 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?
- Therapeutic Drug Monitoring (TDM)
- Type of treatment
- Surgery or procedure
- How many people
- 360 participants
- Where
- 47 sitesin 2 countries
- Study dates
- Jun 2002to Aug 2007
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV infected
- Viral load of 1000 copies/ml or more at study screening
- At least one viral load of 400 copies/ml or more within 6 months of study entry while on the failing antiretroviral regimen
- Virologic failure of at least one combination (two or more drugs) antiretroviral regimen, with at least one of these failing regimens containing a PI. Low dose ritonavir and hydroxyurea are not counted as antiretrovirals.
- Currently on a failing combination antiretroviral regimen
- Plan to initiate a salvage regimen containing a PI within 7 days of study entry
Show all 9Show fewer
- Acceptable methods of contraception while receiving the study medications and for 6 weeks after stopping the medications. Participants who are currently taking efavirenz and who have undergone surgery to prevent conception (e.g., hysterectomy, tubal ligation, vasectomy) must provide physician's documentation of their current regimen and of their previous surgery.
- Resistance to at least one drug in the failing regimen, documented within 90 days of study entry
- Karnofsky performance scale of 70 or more within 30 days prior to study entry
Who cannot join
- Growth factors, interleukins, interferons (except for the treatment of hepatitis C), non-FDA approved systemic drugs, and HIV vaccines within 30 days of study entry
- Require certain medications prior to or during the study
- Certain heart conditions, if starting a PI-based regimen as the salvage regimen
- Acute illness or infection requiring treatment within 14 days of study entry
- Any condition that would limit ability to participate in the study
- Cancer requiring radiation or systemic chemotherapy
Show all 10Show fewer
- Active drug or alcohol use or dependence that would interfere with the ability to meet study requirements
- Acute or chronic pancreatitis
- Planned use of hydroxyurea in the salvage regimen
- Pregnant or breastfeeding
Trial locations and contacts
47 sites in 2 countries.
47 sites in 2 countries
United States46 sites
Univ of Maryland, Institute of Human Virology
Baltimore, Maryland, 21201
Johns Hopkins Univ
Baltimore, Maryland, 21287-8106
Univ of Alabama at Birmingham
Birmingham, Alabama, 35924-2050
Harvard (Masschusetts General Hosp)
Boston, Massachusetts, 02114
Beth Israel Deaconess-West Campus
Boston, Massachusetts, 02215
Brigham and Women's Hosp
Boston, Massachusetts, 02215
SUNY-Buffalo (Rochester)
Buffalo, New York, 14215
University of North Carolina
Chapel Hill, North Carolina, 27514
Northwestern Univ
Chicago, Illinois, 60611-3015
The CORE Ctr
Chicago, Illinois, 60612
Ohio State Univ
Cincinnati, Ohio, 45267-0405
Univ of Cincinnati
Cincinnati, Ohio, 45267-0405
Case Western Reserve Univ
Cleveland, Ohio, 44106
Cleveland Clinic
Cleveland, Ohio, 44109-1998
MetroHealth Med Ctr
Cleveland, Ohio, 44109-1998
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
Duke Univ Med Ctr
Durham, North Carolina, 27710
Univ of Texas, Galveston
Galveston, Texas, 77555-0435
Univ of Hawaii
Honolulu, Hawaii, 96816-2396
Methodist Hosp of Indiana
Indianapolis, Indiana, 46202-1261
Indiana Univ Hosp
Indianapolis, Indiana, 46202-5250
Wishard Hosp
Indianapolis, Indiana, 46202
Univ of Southern California
Los Angeles, California, 90033-1079
UCLA School of Medicine
Los Angeles, California, 90095
Univ of Miami
Miami, Florida, 33136-1013
Univ of Minnesota
Minneapolis, Minnesota, 55455-0392
Comprehensive Care Clinic
Nashville, Tennessee, 37203
Beth Israel Medical Center
New York, New York, 10003
Chelsea Clinic
New York, New York, 10011
New York University - Bellevue
New York, New York, 10016
Long Beach Memorial (Pediatric)
New York, New York, 10021
Columbia Univ
New York, New York, 10032
Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Rhode Island Hosp
Providence, Rhode Island, 02906
Stanley Street Treatment and Resource
Providence, Rhode Island, 02906
The Miriam Hosp
Providence, Rhode Island, 02906
Community Health Network Inc
Rochester, New York, 14642
Univ of Rochester Medical Center
Rochester, New York, 14642
Univ of California, San Diego Antiviral Research Center (AVRC)
San Diego, California, 92103
Univ of California San Francisco
San Francisco, California, 94110
Univ of Washington (Seattle)
Seattle, Washington, 98104
St. Louis Connect Care
St Louis, Missouri, 63108-2138
Washington Univ (St. Louis)
St Louis, Missouri, 63108-2138
San Mateo County AIDS Program
Stanford, California, 94305-5107
Santa Clara Valley Med Ctr
Stanford, California, 94305-5107
Willow Clinic
Stanford, California, 94305-5107
About this study
Official title: A Phase II Randomized Controlled Trial Evaluating the Impact of Therapeutic Drug Monitoring (TDM) on Virologic Response to a Salvage Regimen in Subjects With a Normalized Inhibitory Quotient (NIQ) Less Than or Equal to 1 to One or More Protease Inhibitors
Drug resistance testing can be used to see which anti-HIV drugs are likely to suppress the growth of HIV and to select an anti-HIV regimen for HIV infected patients who have failed previous drug regimens. Therapeutic drug monitoring (TDM) is a process that involves measuring blood levels of a drug and may further increase the benefits that resistance testing offers by optimizing protease inhibitor (PI) drug concentrations. The purpose of this study is to determine whether changing the dose of PIs, as indicated by TDM, reduces the viral load in PI-experienced patients.
Hypothesis: Treatment-naive study participants who undergo TDM and whose clinicians' interpret their TDM results and adjust their PI doses will have better virologic response rates and decreased toxicities (and thus better treatment outcomes) than participants who do not undergo TDM.
Read the detailed description
The use of drug resistance testing to guide the selection of an antiretroviral regimen for patients in whom current therapy is failing has gained growing acceptance in clinical practice. Genotypic and phenotypic resistance testing has been associated with improved short-term virologic outcome in prospective interventional trials. There is also growing evidence that monitoring drug levels, particularly of PIs, may add to the benefit provided by resistance testing. This study will assess the impact of TDM and resistance testing on lowering viral load in treatment-experienced patients and will also evaluate the mean change in plasma HIV RNA from study entry to Step 2 of the study.
No antiretrovirals will be provided by this study. Participants will be followed for a maximum of 48 weeks. Participants failing at least one combination antiretroviral regimen will have a screening drug resistance test performed while remaining on the failing regimen. In Step 1, participants will begin a salvage antiretroviral regimen within 7 days of study entry selected by their clinician using results of the resistance test. Two weeks after initiation of the salvage regimen, participants will have timed plasma samples obtained for PI trough levels. The results of the trough level tests will be used to calculate a normalized inhibitory quotient (NIQ) in order to determine eligibility for randomization into Step 2 at Week 4. Electrocardiograms (EKGs) and trough levels will be performed at Weeks 2, 6, and 10; support interviews to promote adherence will also be conducted by the study nurse or clinician at these times. Some participants taking tipranavir may have additional blood collection at Week 2.
In Step 2, participants with an NIQ of 1 or less will be randomly assigned to one of two arms. Arm A participants will receive standard care (SC) only, while participants in Arm B will receive SC plus dose-adjusted PIs based on the NIQ. Clinical and viral load assessment will be conducted at screening, entry, and Weeks 4, 10, 16, 24, 32, 40, and 48. Arm B participants will also have their PI trough levels checked at Weeks 6 and 10. Participants with an NIQ greater than 1 will be assigned to observational Arm C (open to up to 50 enrollees) or will stop their involvement in the study. Participants in Arms A, B, or C who have a viral load of 1000 copies/ml or higher or who experience virologic failure at or after Week 24 will be eligible to receive a second resistance test and enter Step 3.
Participants in Step 3 will begin a second salvage regimen; PI trough levels will be measured after 2, 6, and 10 weeks of salvage therapy. Those with an NIQ greater than 1, or with an NIQ of 1 or less and do not wish to escalate dose, will be followed on Step 3 for a maximum of 48 weeks after study entry.
All participants are encouraged to coenroll in ACTG A5128, Consent for Use of Stored Patient Specimens for Future Testing.
- Conditions
- HIV Infections
- Being tested
- Therapeutic Drug Monitoring (TDM)
- Keywords
- Drug Therapy, Combination, HIV Protease Inhibitors, Salvage Therapy, Viral Load, 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.
Therapeutic Drug Monitoring (TDM)Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in log10 plasma HIV-1 RNA concentration from Step 2 entry (Week 4) to Week 24 (20 weeks post-randomization)
change in log10 plasma HIV-1 RNA concentration from study entry to Week 24 (20 weeks post-randomization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2002 (estimated)
- Study startJun 2002
- Primary completionApr 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Masking
- None (open label)
- Enrolment
- 360 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Lisa Demeter, MD, Study chair, Infectious Diseases Unit, University of Rochester Medical CenterMary Albrecht, MD, Study chair, Division of Infectious Diseases, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00041769
- Sponsor's protocol ID
- ACTG A5146
- Other IDs
- AACTG A5146
- Status last verified
- Dec 2008
- First submitted
- 16 Jul 2002
- Last updated
- 13 Jul 2010
- Results posted
- No
Publications
Clevenbergh P, Mouly S, Sellier P, Badsi E, Cervoni J, Vincent V, Trout H, Bergmann JF. Improving HIV infection management using antiretroviral plasma drug levels monitoring: a clinician's point of view. Curr HIV Res. 2004 Oct;2(4):309-21. doi: 10.2174/1570162043351129.
PubMed 15544452Duong M, Golzi A, Peytavin G, Piroth L, Froidure M, Grappin M, Buisson M, Kohli E, Chavanet P, Portier H. Usefulness of therapeutic drug monitoring of antiretrovirals in routine clinical practice. HIV Clin Trials. 2004 Jul-Aug;5(4):216-23. doi: 10.1310/NXJU-9ERQ-ADWW-UC5X.
PubMed 15472796Kiser JJ, Anderson PL, Gerber JG. Therapeutic drug monitoring: pharmacologic considerations for antiretroviral drugs. Curr HIV/AIDS Rep. 2005 Jun;2(2):61-7. doi: 10.1007/s11904-005-0020-8.
PubMed 16091250Rakhmanina NY, van den Anker JN, Soldin SJ. Therapeutic drug monitoring of antiretroviral therapy. AIDS Patient Care STDS. 2004 Jan;18(1):7-14. doi: 10.1089/108729104322740866.
PubMed 15006189Rendon A, Nunez M, Jimenez-Nacher I, Gonzalez de Requena D, Gonzalez-Lahoz J, Soriano V. Clinical benefit of interventions driven by therapeutic drug monitoring. HIV Med. 2005 Sep;6(5):360-5. doi: 10.1111/j.1468-1293.2005.00321.x.
PubMed 16156885DiFrancesco R, Rosenkranz S, Mukherjee AL, Demeter LM, Jiang H, DiCenzo R, Dykes C, Rinehart A, Albrecht M, Morse GD. Quality assessment for therapeutic drug monitoring in AIDS Clinical Trials Group (ACTG 5146): a multicenter clinical trial. Ther Drug Monit. 2010 Aug;32(4):458-66. doi: 10.1097/FTD.0b013e3181e4427a.
PubMed 20592644
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Controlled Trial Evaluating the Impact of Therapeutic Drug Monitoring (TDM) on Virologic Response to a Salvage Regimen in Subjects With a Normalized Inhibitory Quotient (NIQ) Less Than or Equal to 1 to One or More Protease Inhibitors
- ClinicalTrials.gov ID
- NCT00041769
- Acronym / sponsor ID
- ACTG A5146
- Conditions
- HIV Infections
- Keywords
- Drug Therapy, Combination, HIV Protease Inhibitors, Salvage Therapy, Viral Load, Treatment Experienced
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Jun 2002
- Primary completion
- Apr 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 17 Jul 2002 (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.
Drug resistance testing can be used to see which anti-HIV drugs are likely to suppress the growth of HIV and to select an anti-HIV regimen for HIV infected patients who have failed previous drug regimens. Therapeutic drug monitoring (TDM) is a process that involves measuring blood levels of a drug and may further increase the benefits that resistance testing offers by optimizing protease inhibitor (PI) drug concentrations. The purpose of this study is to determine whether changing the dose of PIs, as indicated by TDM, reduces the viral load in PI-experienced patients.
Hypothesis: Treatment-naive study participants who undergo TDM and whose clinicians' interpret their TDM results and adjust their PI doses will have better virologic response rates and decreased toxicities (and thus better treatment outcomes) than participants who do not undergo TDM.
Detailed description
The use of drug resistance testing to guide the selection of an antiretroviral regimen for patients in whom current therapy is failing has gained growing acceptance in clinical practice. Genotypic and phenotypic resistance testing has been associated with improved short-term virologic outcome in prospective interventional trials. There is also growing evidence that monitoring drug levels, particularly of PIs, may add to the benefit provided by resistance testing. This study will assess the impact of TDM and resistance testing on lowering viral load in treatment-experienced patients and will also evaluate the mean change in plasma HIV RNA from study entry to Step 2 of the study.
No antiretrovirals will be provided by this study. Participants will be followed for a maximum of 48 weeks. Participants failing at least one combination antiretroviral regimen will have a screening drug resistance test performed while remaining on the failing regimen. In Step 1, participants will begin a salvage antiretroviral regimen within 7 days of study entry selected by their clinician using results of the resistance test. Two weeks after initiation of the salvage regimen, participants will have timed plasma samples obtained for PI trough levels. The results of the trough level tests will be used to calculate a normalized inhibitory quotient (NIQ) in order to determine eligibility for randomization into Step 2 at Week 4. Electrocardiograms (EKGs) and trough levels will be performed at Weeks 2, 6, and 10; support interviews to promote adherence will also be conducted by the study nurse or clinician at these times. Some participants taking tipranavir may have additional blood collection at Week 2.
In Step 2, participants with an NIQ of 1 or less will be randomly assigned to one of two arms. Arm A participants will receive standard care (SC) only, while participants in Arm B will receive SC plus dose-adjusted PIs based on the NIQ. Clinical and viral load assessment will be conducted at screening, entry, and Weeks 4, 10, 16, 24, 32, 40, and 48. Arm B participants will also have their PI trough levels checked at Weeks 6 and 10. Participants with an NIQ greater than 1 will be assigned to observational Arm C (open to up to 50 enrollees) or will stop their involvement in the study. Participants in Arms A, B, or C who have a viral load of 1000 copies/ml or higher or who experience virologic failure at or after Week 24 will be eligible to receive a second resistance test and enter Step 3.
Participants in Step 3 will begin a second salvage regimen; PI trough levels will be measured after 2, 6, and 10 weeks of salvage therapy. Those with an NIQ greater than 1, or with an NIQ of 1 or less and do not wish to escalate dose, will be followed on Step 3 for a maximum of 48 weeks after study entry.
All participants are encouraged to coenroll in ACTG A5128, Consent for Use of Stored Patient Specimens for Future Testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- 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 (9 listed)
- HIV infected
- Viral load of 1000 copies/ml or more at study screening
- At least one viral load of 400 copies/ml or more within 6 months of study entry while on the failing antiretroviral regimen
- Virologic failure of at least one combination (two or more drugs) antiretroviral regimen, with at least one of these failing regimens containing a PI. Low dose ritonavir and hydroxyurea are not counted as antiretrovirals.
- Currently on a failing combination antiretroviral regimen
Key exclusion criteria (10 listed)
- Growth factors, interleukins, interferons (except for the treatment of hepatitis C), non-FDA approved systemic drugs, and HIV vaccines within 30 days of study entry
- Require certain medications prior to or during the study
- Certain heart conditions, if starting a PI-based regimen as the salvage regimen
- Acute illness or infection requiring treatment within 14 days of study entry
- Any condition that would limit ability to participate in the study
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 |
|---|---|---|
| Therapeutic Drug Monitoring (TDM) | Procedure or surgery | – |
Primary outcome
Change in log10 plasma HIV-1 RNA concentration from Step 2 entry (Week 4) to Week 24 (20 weeks post-randomization)
change in log10 plasma HIV-1 RNA concentration from study entry to Week 24 (20 weeks post-randomization)
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 13 Jul 2010.
- Background: PubMed 15544452Clevenbergh P, Mouly S, Sellier P, Badsi E, Cervoni J, Vincent V, Trout H, Bergmann JF. Improving HIV infection management using antiretroviral plasma drug levels monitoring: a clinician's point of view. Curr HIV Res. 2004 Oct;2(4):309-21. doi: 10.2174/1570162043351129.
- Background: PubMed 15472796Duong M, Golzi A, Peytavin G, Piroth L, Froidure M, Grappin M, Buisson M, Kohli E, Chavanet P, Portier H. Usefulness of therapeutic drug monitoring of antiretrovirals in routine clinical practice. HIV Clin Trials. 2004 Jul-Aug;5(4):216-23. doi: 10.1310/NXJU-9ERQ-ADWW-UC5X.
- Background: PubMed 16091250Kiser JJ, Anderson PL, Gerber JG. Therapeutic drug monitoring: pharmacologic considerations for antiretroviral drugs. Curr HIV/AIDS Rep. 2005 Jun;2(2):61-7. doi: 10.1007/s11904-005-0020-8.
- Background: PubMed 15006189Rakhmanina NY, van den Anker JN, Soldin SJ. Therapeutic drug monitoring of antiretroviral therapy. AIDS Patient Care STDS. 2004 Jan;18(1):7-14. doi: 10.1089/108729104322740866.
- Background: PubMed 16156885Rendon A, Nunez M, Jimenez-Nacher I, Gonzalez de Requena D, Gonzalez-Lahoz J, Soriano V. Clinical benefit of interventions driven by therapeutic drug monitoring. HIV Med. 2005 Sep;6(5):360-5. doi: 10.1111/j.1468-1293.2005.00321.x.
- Results publication: PubMed 20592644DiFrancesco R, Rosenkranz S, Mukherjee AL, Demeter LM, Jiang H, DiCenzo R, Dykes C, Rinehart A, Albrecht M, Morse GD. Quality assessment for therapeutic drug monitoring in AIDS Clinical Trials Group (ACTG 5146): a multicenter clinical trial. Ther Drug Monit. 2010 Aug;32(4):458-66. doi: 10.1097/FTD.0b013e3181e4427a.
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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.
Lisa Demeter, MD study chair
Infectious Diseases Unit, University of Rochester Medical Center
Mary Albrecht, MD study chair
Division of Infectious Diseases, Beth Israel Deaconess Medical Center
47 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Therapeutic Drug Monitoring (TDM) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 47 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 9 inclusion and 10 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 13 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 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 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?
Change in log10 plasma HIV-1 RNA concentration from Step 2 entry (Week 4) to Week 24 (20 weeks post-randomization). The study lists 2 primary outcomes in all. 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 NCT00041769, which also lists 6 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 13 Jul 2010; AzTrials last refreshed its copy on 7 Nov 2026.