HIV InfectionsNCT00005915
A Comparison of Two Anti-HIV Treatment Plans
An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 21 sites in United States.
Trial summary
The purpose of this study is to compare 2 treatment plans to try to increase the effects of anti-HIV drugs in patients who are resistant to the drug effects. Sometimes the increase in a patient's viral load (the level of HIV in the blood) can be slowed or stopped by taking anti-HIV drugs. This does not always happen. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- HIV Infections
- How many people
- 480 participants
- Where
- 21 sitesUnited States
- Study dates
- Start not givento Jun 2004
- Phase
- Observational
- 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 if they:
- Have proof of MDR virus from a blood test.
- Have a viral load above 5,000 copies/ml from the same blood sample showing MDR virus.
- Intend to start a new anti-HIV treatment around the time of the study.
- Have been on a stable anti-HIV treatment between 14 days prior to the blood test mentioned above and when they are randomly assigned to a treatment.
- Are at least 13 years old (consent of parent or guardian required if under 18).
- (This protocol has been changed to reflect new criteria.)
Who cannot join
- Patients will not be eligible if they:
- Have received a vaccine or had an illness that might affect viral load within 14 days before the blood test showing MDR virus.
- Have received IL-2 within 4 months of the above-mentioned blood test or plan to take IL-2 during the study.
- Have an opportunistic (AIDS-related) infection requiring treatment.
- Are pregnant or breast-feeding.
- Are currently participating in CPCRA 057 (PIP study).
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Southern New Jersey AIDS Clinical Trials
Camden, New Jersey, 08103
AIDS Research Alliance - Chicago
Chicago, Illinois, 60657
Denver CPCRA / Denver Public Hlth
Denver, Colorado, 80204
Univ Hosp Infectious Disease
Denver, Colorado, 80204
Wayne State Univ - WSU/DMC / Univ Hlth Ctr
Detroit, Michigan, 48201
Henry Ford Hosp
Detroit, Michigan, 48202
Montrose Clinic
Houston, Texas, 77006
Houston Veterans Administration Med Ctr
Houston, Texas, 77030
Univ TX Health Science Ctr
Houston, Texas, 77030
Yale U / New Haven Med Ctr / AIDS Clinical Trials Unit
New Haven, Connecticut, 06510
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, 70112
Our Lady of the Lake Regional Med Ctr
New Orleans, Louisiana, 70112
Harlem AIDS Treatment Grp / Harlem Hosp Ctr
New York, New York, 10037
North Jersey Community Research Initiative
Newark, New Jersey, 07103
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107
The Research and Education Group
Portland, Oregon, 97210
Richmond AIDS Consortium / Div of Infect Diseases
Richmond, Virginia, 23298
Community Consortium / UCSF
San Francisco, California, 94110
Lawrence Goldyn, MD
San Francisco, California, 94110
Bronx-Lebanon Hosp Ctr
The Bronx, New York, 10453
Washington Reg AIDS Prog / Dept of Infect Dis
Washington D.C., District of Columbia, 20422
About this study
Official title: A Randomized Study of a Prescribed 4-Month Structured Treatment Interruption (STI) Followed by Initiation of a New Antiretroviral Regimen Versus Immediate Initiation of a New Antiretroviral Regimen in HIV-Infected Patients With Multidrug Resistant (MDR) Virus
The purpose of this study is to compare 2 treatment plans to try to increase the effects of anti-HIV drugs in patients who are resistant to the drug effects.
Sometimes the increase in a patient's viral load (the level of HIV in the blood) can be slowed or stopped by taking anti-HIV drugs. This does not always happen. Sometimes anti-HIV drugs work at first but then stop working. When most of the usual anti-HIV drugs no longer seem to work, the virus is called multidrug-resistant (MDR). This study will compare 2 treatment plans to try to increase the effects of anti-HIV drugs in patients with MDR virus.
Read the detailed description
An increasing number of patients are developing multidrug-resistant (MDR) virus, as determined by genotypic antiretroviral resistance testing (GART), due to treatment failure to suppress viral replication after several rounds of combination antiretroviral therapy. The best therapeutic strategy for these patients is uncertain. Two strategies currently being used are (1) STI followed by a new antiretroviral regimen and (2) immediate initiation of a new antiretroviral regimen.
Patients are screened for the presence of MDR virus and a plasma HIV RNA level greater than 10,000 [AS PER AMENDMENT 07/03/01: greater than 5,000] copies/ml. Eligible patients attend a baseline visit [AS PER AMENDMENT 07/03/01: and a subsequent randomization visit] where the qualifying GART results are provided. Patients who consent to participate have phenotypic antiretroviral resistance testing (PART) done on a specimen from the same blood draw that was used for the GART evaluation. After PART results are available, patients are randomized [AS PER AMENDMENT 07/03/01: If the predicted sensitivities are not available for some or all drugs included in the PART, the patient may still be randomized.] to either a 4-month STI followed by a new antiretroviral regimen or an immediate new antiretroviral regimen. The antiretroviral regimens chosen are based on the patients' history and both GART and PART results. [AS PER AMENDMENT 07/03/01: Additional GART and PART may be requested after at least 4 months of antiretroviral treatment.] Patients have the follow-up data collection done at Months 1-8 and every 4 months thereafter. Changes in antiretroviral therapy, Grade 4 adverse experiences, progression of disease, and deaths are reported as they occur. Patients are seen for clinical management as often as deemed necessary. All patients are followed to a common closing date estimated to be 24 months after the last patient is randomized. Some patients may participate in a Point Mutation Substudy [AS PER AMENDMENT 07/03/01: Plasma Point Mutation Substudy and PBMC Point Mutation Substudy].
- Conditions
- HIV Infections
- Keywords
- HIV-1, Drug Administration Schedule, Drug Resistance, Microbial, Disease Progression, Genotype, Phenotype, Drug Resistance, Multiple, Anti-HIV Agents, Treatment Experienced
- Medical subject headings
- HIV Infections, Disease Progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Observational
- Enrolment
- 480 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Jody Lawrence, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005915
- Sponsor's protocol ID
- CPCRA 064
- Other IDs
- 11619
- Status last verified
- Sep 2013
- First submitted
- 15 Jun 2000
- Last updated
- 1 Oct 2013
- Results posted
- No
Publications
Lawrence J, Mayers DL, Hullsiek KH, Collins G, Abrams DI, Reisler RB, Crane LR, Schmetter BS, Dionne TJ, Saldanha JM, Jones MC, Baxter JD; 064 Study Team of the Terry Beirn Community Programs for Clinical Research on AIDS. Structured treatment interruption in patients with multidrug-resistant human immunodeficiency virus. N Engl J Med. 2003 Aug 28;349(9):837-46. doi: 10.1056/NEJMoa035103.
PubMed 12944569Anti-HIV agents. An attempt at treatment interruption--trial CPCRA 064. TreatmentUpdate. 2003 Aug-Sep;15(5):4-5. No abstract available.
PubMed 17216857Lawrence J, Hullsiek KH, Thackeray LM, Abrams DI, Crane LR, Mayers DL, Jones MC, Saldanha JM, Schmetter BS, Baxter JD. Disadvantages of structured treatment interruption persist in patients with multidrug-resistant HIV-1: final results of the CPCRA 064 study. J Acquir Immune Defic Syndr. 2006 Oct 1;43(2):169-78. doi: 10.1097/01.qai.0000242450.74779.ee.
PubMed 16951642Paquet AC, Baxter J, Weidler J, Lie Y, Lawrence J, Kim R, Bates M, Coakley E, Chappey C. Differences in reversion of resistance mutations to wild-type under structured treatment interruption and related increase in replication capacity. PLoS One. 2011 Jan 31;6(1):e14638. doi: 10.1371/journal.pone.0014638.
PubMed 21297946
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of a Prescribed 4-Month Structured Treatment Interruption (STI) Followed by Initiation of a New Antiretroviral Regimen Versus Immediate Initiation of a New Antiretroviral Regimen in HIV-Infected Patients With Multidrug Resistant (MDR) Virus
- ClinicalTrials.gov ID
- NCT00005915
- Acronym / sponsor ID
- CPCRA 064
- Conditions
- HIV Infections
- Keywords
- HIV-1, Drug Administration Schedule, Drug Resistance, Microbial, Disease Progression, Genotype, Phenotype, Drug Resistance, Multiple, Anti-HIV Agents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 480 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Jun 2004 (actual)
- First posted
- 31 Aug 2001 (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 2 treatment plans to try to increase the effects of anti-HIV drugs in patients who are resistant to the drug effects.
Sometimes the increase in a patient's viral load (the level of HIV in the blood) can be slowed or stopped by taking anti-HIV drugs. This does not always happen. Sometimes anti-HIV drugs work at first but then stop working. When most of the usual anti-HIV drugs no longer seem to work, the virus is called multidrug-resistant (MDR). This study will compare 2 treatment plans to try to increase the effects of anti-HIV drugs in patients with MDR virus.
Detailed description
An increasing number of patients are developing multidrug-resistant (MDR) virus, as determined by genotypic antiretroviral resistance testing (GART), due to treatment failure to suppress viral replication after several rounds of combination antiretroviral therapy. The best therapeutic strategy for these patients is uncertain. Two strategies currently being used are (1) STI followed by a new antiretroviral regimen and (2) immediate initiation of a new antiretroviral regimen.
Patients are screened for the presence of MDR virus and a plasma HIV RNA level greater than 10,000 [AS PER AMENDMENT 07/03/01: greater than 5,000] copies/ml. Eligible patients attend a baseline visit [AS PER AMENDMENT 07/03/01: and a subsequent randomization visit] where the qualifying GART results are provided. Patients who consent to participate have phenotypic antiretroviral resistance testing (PART) done on a specimen from the same blood draw that was used for the GART evaluation. After PART results are available, patients are randomized [AS PER AMENDMENT 07/03/01: If the predicted sensitivities are not available for some or all drugs included in the PART, the patient may still be randomized.] to either a 4-month STI followed by a new antiretroviral regimen or an immediate new antiretroviral regimen. The antiretroviral regimens chosen are based on the patients' history and both GART and PART results. [AS PER AMENDMENT 07/03/01: Additional GART and PART may be requested after at least 4 months of antiretroviral treatment.] Patients have the follow-up data collection done at Months 1-8 and every 4 months thereafter. Changes in antiretroviral therapy, Grade 4 adverse experiences, progression of disease, and deaths are reported as they occur. Patients are seen for clinical management as often as deemed necessary. All patients are followed to a common closing date estimated to be 24 months after the last patient is randomized. Some patients may participate in a Point Mutation Substudy [AS PER AMENDMENT 07/03/01: Plasma Point Mutation Substudy and PBMC Point Mutation Substudy].
Study design
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Have proof of MDR virus from a blood test.
- Have a viral load above 5,000 copies/ml from the same blood sample showing MDR virus.
- Intend to start a new anti-HIV treatment around the time of the study.
- Have been on a stable anti-HIV treatment between 14 days prior to the blood test mentioned above and when they are randomly assigned to a treatment.
- Are at least 13 years old (consent of parent or guardian required if under 18).
Key exclusion criteria (6 listed)
- Have received a vaccine or had an illness that might affect viral load within 14 days before the blood test showing MDR virus.
- Have received IL-2 within 4 months of the above-mentioned blood test or plan to take IL-2 during the study.
- Have an opportunistic (AIDS-related) infection requiring treatment.
- Are pregnant or breast-feeding.
- Are currently participating in CPCRA 057 (PIP study).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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 1 Oct 2013.
- Background: PubMed 12944569Lawrence J, Mayers DL, Hullsiek KH, Collins G, Abrams DI, Reisler RB, Crane LR, Schmetter BS, Dionne TJ, Saldanha JM, Jones MC, Baxter JD; 064 Study Team of the Terry Beirn Community Programs for Clinical Research on AIDS. Structured treatment interruption in patients with multidrug-resistant human immunodeficiency virus. N Engl J Med. 2003 Aug 28;349(9):837-46. doi: 10.1056/NEJMoa035103.
- Results publication: PubMed 17216857Anti-HIV agents. An attempt at treatment interruption--trial CPCRA 064. TreatmentUpdate. 2003 Aug-Sep;15(5):4-5. No abstract available.
- Results publication: PubMed 16951642Lawrence J, Hullsiek KH, Thackeray LM, Abrams DI, Crane LR, Mayers DL, Jones MC, Saldanha JM, Schmetter BS, Baxter JD. Disadvantages of structured treatment interruption persist in patients with multidrug-resistant HIV-1: final results of the CPCRA 064 study. J Acquir Immune Defic Syndr. 2006 Oct 1;43(2):169-78. doi: 10.1097/01.qai.0000242450.74779.ee.
- Results publication: PubMed 21297946Paquet AC, Baxter J, Weidler J, Lie Y, Lawrence J, Kim R, Bates M, Coakley E, Chappey C. Differences in reversion of resistance mutations to wild-type under structured treatment interruption and related increase in replication capacity. PLoS One. 2011 Jan 31;6(1):e14638. doi: 10.1371/journal.pone.0014638.
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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.
Jody Lawrence study chair
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 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 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study 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 NCT00005915, which also lists 4 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 1 Oct 2013.