HIV InfectionsPhase 2NCT00036465
Effects of Changing HIV Therapy at Lower Versus Higher Viral Loads
A Phase 2 study testing Treatment regimen change in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 23 sites in United States.
Trial summary
This study will look at people who have been taking anti-HIV drugs but still have detectable levels of HIV. The purpose of the study is to find out what happens in those people who change anti-HIV drugs when their viral load reaches 200 copies compared to those who change anti-HIV drugs when their viral load reaches… Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Treatment regimen change
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 23 sitesUnited States
- Study dates
- Start not givento Sep 2005
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients may be eligible for this study if they:
- Are HIV-infected.
- Have a CD4 cell count of 200 cells/mm3 or more within 45 days prior to entry.
- Are currently receiving the same HAART regimen for at least 4 months.
- Had a documented viral load of less than 500 copies/ml at any time prior to screening on the current stable antiretroviral regimen.
- Have a detectable plasma viral load on current stable anti-HIV regimen, as defined in the protocol, within 52 weeks prior to screening.
Show all 11Show fewer
- Are willing to remain on their current regimen until their scheduled switch.
- Have a negative pregnancy test within 48 hours prior to entry.
- Are at least 13 years old.
- Agree not to participate in the conception process (active attempts to become pregnant or to make someone pregnant) while on study and for 60 days after going off study.
- Agree to use 2 acceptable forms of contraception while on study and for 60 days after going off study.
Who cannot join
- Patients may not be eligible for this study if they:
- Do not adhere with current antiretroviral therapy.
- Have an infection or cancer that requires treatment within 45 days prior to entry.
- Are pregnant or breast-feeding.
- Have used any experimental agents, systemic corticosteroids, or drugs that interfere with the immune system within 45 days prior to entry.
- Have received any HIV vaccine within 90 days prior to entry.
- Use drugs or alcohol that, in the opinion of the investigator, would interfere with the study.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Harvard (Masschusetts General Hosp)
Boston, Massachusetts, 02114
Brigham and Womens Hosp
Boston, Massachusetts, 02215
Univ of North Carolina
Chapel Hill, North Carolina, 27599-7215
Northwestern Univ
Chicago, Illinois, 60611
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
The CORE Ctr
Chicago, Illinois, 60612
Univ of Cincinnati
Cincinnati, Ohio, 452670405
Univ of Texas, Southwestern Med Ctr of Dallas
Dallas, Texas, 75390
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
Duke Univ Med Ctr
Durham, North Carolina, 27710
Univ of Texas Galveston
Galveston, Texas, 775550435
Univ of Hawaii
Honolulu, Hawaii, 96816
Willow Clinic
Menlo Park, California, 94025
Univ of Miami School of Medicine
Miami, Florida, 331361013
Comprehensive Care Clinic / Vanderbilt Univ Med Ctr
Nashville, Tennessee, 37203
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016
Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Brown Univ / Miriam Hosp
Providence, Rhode Island, 02906
Miriam Hosp / Brown Univ
Providence, Rhode Island, 02906
Univ of Washington
Seattle, Washington, 98104
San Mateo AIDS Program / Stanford Univ
Stanford, California, 94305-5107
Stanford Univ Med Ctr
Stanford, California, 94305-5107
Harbor General/UCLA
Torrance, California, 90502-2052
About this study
Official title: A Phase II, Randomized, Controlled, Pilot Study of Antiretroviral Switch at Lower Versus Higher HIV-1 RNA Levels in Subjects Experiencing Virologic Relapse on a Current HAART Regimen
This study will look at people who have been taking anti-HIV drugs but still have detectable levels of HIV. The purpose of the study is to find out what happens in those people who change anti-HIV drugs when their viral load reaches 200 copies compared to those who change anti-HIV drugs when their viral load reaches 10,000 copies. This study will also look at drug resistance (how well HIV responds to drugs), viral fitness (how well drug-resistant HIV copies itself), and immunologic reconstitution (how well the immune system recognizes various infections, including HIV).
Many patients experience virologic relapse (increase in viral load after sustained viral load suppression) within 1 to 2 years of taking anti-HIV drugs. The approach to treatment for patients who experience virologic relapse while on a highly active antiretroviral therapy (HAART) has not been defined. Current guidelines recommend switching to a new treatment regimen as soon as possible to prevent HIV from becoming even more resistant to anti-HIV drugs. However, there is evidence that patients can benefit from staying on the same HAART drugs, even after virologic relapse. This study wants to find what happens when drugs are changed immediately after virologic relapse (when the viral load is lower) compared to what happens if drugs are changed only after a delay (when the viral load is higher).
Read the detailed description
Virologic relapse occurs within 1 to 2 years of antiretroviral therapy in up to 50 percent of HIV-infected individuals. The best treatment approach for patients who experience virologic rebound while on highly active antiretroviral therapy (HAART) has not been defined. Current guidelines recommend switching to a new treatment regimen shortly after virologic rebound in an effort to avoid sequential accumulation of multiple resistance mutations. However, early treatment switching has numerous disadvantages: risk of virologic rebound on the new therapy, a limited number of drug combinations available to treat such rebounds, and difficulty in obtaining early genotypic and phenotypic drug-resistance information to guide treatment modification. Delaying a switch to a new antiretroviral regimen has the advantage of preserving future treatment options, and HIV levels may remain partially suppressed even after drug-resistant mutants emerge. Moreover, several observational studies describe maintenance of immunologic and clinical benefits of HAART even after virologic rebound. Delayed treatment switches, however, raise concerns about sequential accumulation of drug resistance mutations that may diminish the chances of viral resuppression with successive HAART regimens, and the long-term immune consequences of virologic rebound on HAART are not known. It is therefore important to evaluate the viral and immunologic responses among patients randomized to either an early or delayed HAART switch.
This study enrolls patients who have a viral load of at least 200, but less than 10,000 copies/ml. The patients are randomized into 2 treatment arms. Arm A (immediate switch) patients have genotypic resistance testing at entry. Based on the resistance test results, their antiretroviral treatment regimen is modified to a switch treatment regimen. Switch treatment initiates no later than Week 4. Arm B (delayed switch) patients continue their current antiretroviral regimen and have genotypic resistance testing when their plasma HIV-1 RNA levels reach 10,000 copies/ml or greater. Based on the resistance test results, their antiretroviral treatment regimen is modified to a switch treatment regimen. Switch treatment initiates no later than 4 weeks from the date of at least 10,000 copies/ml viral load, or from the date of an absolute CD4 count reduced by 20 percent from baseline value. Patients who never meet the switch criteria remain on study.
All patients are followed for a minimum of 48 weeks after entry. No antiretroviral drugs are provided by the study.
- Conditions
- HIV Infections
- Being tested
- Treatment regimen change
- Keywords
- Pilot Projects, HIV-1, RNA, Viral, Genotype, Viral Load, Antiretroviral Therapy, Highly Active, 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.
Treatment regimen changeBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2002 (estimated)
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 60 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Sharon Riddler, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00036465
- Sponsor's protocol ID
- A5115
- Other IDs
- AACTG A5115, ACTG A5115, 10933
- Status last verified
- Jul 2013
- First submitted
- 10 May 2002
- Last updated
- 29 Jul 2013
- Results posted
- No
Publications
Riddler SA, Jiang H, Tenorio A, Huang H, Kuritzkes DR, Acosta EP, Landay A, Bastow B, Haas DW, Tashima KT, Jain MK, Deeks SG, Bartlett JA. A randomized study of antiviral medication switch at lower- versus higher-switch thresholds: AIDS Clinical Trials Group Study A5115. Antivir Ther. 2007;12(4):531-41. doi: 10.1177/135965350701200415.
PubMed 17668562
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Controlled, Pilot Study of Antiretroviral Switch at Lower Versus Higher HIV-1 RNA Levels in Subjects Experiencing Virologic Relapse on a Current HAART Regimen
- ClinicalTrials.gov ID
- NCT00036465
- Acronym / sponsor ID
- A5115
- Conditions
- HIV Infections
- Keywords
- Pilot Projects, HIV-1, RNA, Viral, Genotype, Viral Load, Antiretroviral Therapy, Highly Active, Treatment Experienced
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Sep 2005 (actual)
- First posted
- 13 May 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.
This study will look at people who have been taking anti-HIV drugs but still have detectable levels of HIV. The purpose of the study is to find out what happens in those people who change anti-HIV drugs when their viral load reaches 200 copies compared to those who change anti-HIV drugs when their viral load reaches 10,000 copies. This study will also look at drug resistance (how well HIV responds to drugs), viral fitness (how well drug-resistant HIV copies itself), and immunologic reconstitution (how well the immune system recognizes various infections, including HIV).
Many patients experience virologic relapse (increase in viral load after sustained viral load suppression) within 1 to 2 years of taking anti-HIV drugs. The approach to treatment for patients who experience virologic relapse while on a highly active antiretroviral therapy (HAART) has not been defined. Current guidelines recommend switching to a new treatment regimen as soon as possible to prevent HIV from becoming even more resistant to anti-HIV drugs. However, there is evidence that patients can benefit from staying on the same HAART drugs, even after virologic relapse. This study wants to find what happens when drugs are changed immediately after virologic relapse (when the viral load is lower) compared to what happens if drugs are changed only after a delay (when the viral load is higher).
Detailed description
Virologic relapse occurs within 1 to 2 years of antiretroviral therapy in up to 50 percent of HIV-infected individuals. The best treatment approach for patients who experience virologic rebound while on highly active antiretroviral therapy (HAART) has not been defined. Current guidelines recommend switching to a new treatment regimen shortly after virologic rebound in an effort to avoid sequential accumulation of multiple resistance mutations. However, early treatment switching has numerous disadvantages: risk of virologic rebound on the new therapy, a limited number of drug combinations available to treat such rebounds, and difficulty in obtaining early genotypic and phenotypic drug-resistance information to guide treatment modification. Delaying a switch to a new antiretroviral regimen has the advantage of preserving future treatment options, and HIV levels may remain partially suppressed even after drug-resistant mutants emerge. Moreover, several observational studies describe maintenance of immunologic and clinical benefits of HAART even after virologic rebound. Delayed treatment switches, however, raise concerns about sequential accumulation of drug resistance mutations that may diminish the chances of viral resuppression with successive HAART regimens, and the long-term immune consequences of virologic rebound on HAART are not known. It is therefore important to evaluate the viral and immunologic responses among patients randomized to either an early or delayed HAART switch.
This study enrolls patients who have a viral load of at least 200, but less than 10,000 copies/ml. The patients are randomized into 2 treatment arms. Arm A (immediate switch) patients have genotypic resistance testing at entry. Based on the resistance test results, their antiretroviral treatment regimen is modified to a switch treatment regimen. Switch treatment initiates no later than Week 4. Arm B (delayed switch) patients continue their current antiretroviral regimen and have genotypic resistance testing when their plasma HIV-1 RNA levels reach 10,000 copies/ml or greater. Based on the resistance test results, their antiretroviral treatment regimen is modified to a switch treatment regimen. Switch treatment initiates no later than 4 weeks from the date of at least 10,000 copies/ml viral load, or from the date of an absolute CD4 count reduced by 20 percent from baseline value. Patients who never meet the switch criteria remain on study.
All patients are followed for a minimum of 48 weeks after entry. No antiretroviral drugs are provided by the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Are HIV-infected.
- Have a CD4 cell count of 200 cells/mm3 or more within 45 days prior to entry.
- Are currently receiving the same HAART regimen for at least 4 months.
- Had a documented viral load of less than 500 copies/ml at any time prior to screening on the current stable antiretroviral regimen.
- Have a detectable plasma viral load on current stable anti-HIV regimen, as defined in the protocol, within 52 weeks prior to screening.
Key exclusion criteria (7 listed)
- Do not adhere with current antiretroviral therapy.
- Have an infection or cancer that requires treatment within 45 days prior to entry.
- Are pregnant or breast-feeding.
- Have used any experimental agents, systemic corticosteroids, or drugs that interfere with the immune system within 45 days prior to entry.
- Have received any HIV vaccine within 90 days prior to 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 |
|---|---|---|
| Treatment regimen change | Behavioural | – |
Primary outcome
Not reported in the source record.
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 29 Jul 2013.
- Derived from this study: PubMed 17668562Riddler SA, Jiang H, Tenorio A, Huang H, Kuritzkes DR, Acosta EP, Landay A, Bastow B, Haas DW, Tashima KT, Jain MK, Deeks SG, Bartlett JA. A randomized study of antiviral medication switch at lower- versus higher-switch thresholds: AIDS Clinical Trials Group Study A5115. Antivir Ther. 2007;12(4):531-41. doi: 10.1177/135965350701200415.
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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.
Sharon Riddler study chair
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Treatment regimen change in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 23 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 11 inclusion and 7 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 29 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00036465, which also lists 1 linked publication.
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 Jul 2013.