AIDSOPTIMANCT00050089
CSP #512 - Options in Management With Anti-Retrovirals
A study testing No Antiretroviral Drug-Free Period (No ARDFP) vs ARDFP and Standard ART vs Mega ART in people with AIDS and HIV Infections, run by US Department of Veterans Affairs at 30 sites in 2 countries.
Trial summary
This 'pragmatic' trial is a 2X2 open randomized study of patients in advanced HIV disease who have failed on conventional Highly Active Antiretroviral Therapy (HAART) regimens including all three classes of anti-HIV drugs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AIDS, HIV Infections
- What is being tested?
- No Antiretroviral Drug-Free Period (No ARDFP) vs ARDFP and Standard ART vs Mega ART
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 368 participants
- Where
- 30 sitesin 2 countries
- Study dates
- Jan 2001to Dec 2007
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Ability to provide informed consent
- Age of 18 years or more
- Serologic or virologic diagnosis of HIV infection
- Failure of at least two different multi-drug regimens that include drugs of all 3 classes that the patient can tolerate or laboratory evidence of resistance to drugs in each of the 3 classes
- Had at least 3 months of current ART and are still on treatment
- Two most recent results (which can include screening) on current ART of CD4 count less than or equal to 300 cells/mm3 or less than or equal to 15%, and a plasma viral load greater than or equal to 5,000 copies/ml (Roche Amplicor, v1.0), or greater than or equal to 2,500 copies/ml (by bDNA: Bayer v3.0/Chiron v3.0 or PCR:Roche Amplicor Monitor/COBAS v1.5)
Who cannot join
- Pregnancy, breast-feeding or planned pregnancy
- Likelihood of poor protocol follow-up or if Mega-Art is not feasible (due to significant intolerance of many ARV drugs)
- Serious, uncontrolled major opportunistic infection (OI) within 14 days of screening
- Likelihood of early death due to non-HIV disease
Trial locations and contacts
30 sites in 2 countries.
30 sites in 2 countries
United States29 sites
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, 48113
VA Maryland Health Care System, Baltimore
Baltimore, Maryland, 21201
VA Medical Center, Jamaica Plain Campus
Boston, Massachusetts, 02130
Jesse Brown VAMC (WestSide Division)
Chicago, Illinois, 60612
VA Medical Center, Cincinnati
Cincinnati, Ohio, 45220
VA Medical Center, Cleveland
Cleveland, Ohio, 44106
WJB Dorn Veterans Hospital, Columbia
Columbia, South Carolina, 29209
VA North Texas Health Care System, Dallas
Dallas, Texas, 75216
Atlanta VA Medical and Rehab Center, Decatur
Decatur, Georgia, 30033
VA Medical Center, Durham
Durham, North Carolina, 27705
VA New Jersey Health Care System, East Orange
East Orange, New Jersey, 07018
North Florida/South Georgia Veterans Health System
Gainesville, Florida, 32608
Edward Hines, Jr. VA Hospital
Hines, Illinois, 60141-5000
Michael E. DeBakey VA Medical Center (152)
Houston, Texas, 77030
VA Medical Center, Long Beach
Long Beach, California, 90822
VA Medical Center, Miami
Miami, Florida, 33125
New York Harbor HCS
New York, New York, 10010
VA Palo Alto Health Care System
Palo Alto, California, 94304-1290
VA Medical Center, Philadelphia
Philadelphia, Pennsylvania, 19104
Carl T. Hayden VA Medical Center
Phoenix, Arizona, 85012
VA Medical Center, Portland
Portland, Oregon, 97201
VA South Texas Health Care System, San Antonio
San Antonio, Texas, 78229
VA San Diego Healthcare System, San Diego
San Diego, California, 92161
Bay Pines VAMC (111J)
St. Petersburg, Florida, 33708
VA Medical Center, Bronx
The Bronx, New York, 10468
VA Medical Center, DC
Washington D.C., District of Columbia, 20422
VA Connecticut Health Care System (West Haven)
West Haven, Connecticut, 06516
VA Greater Los Angeles Healthcare System, West LA
West Los Angeles, California, 90073
West Palm Beach VA Medical Center
West Palm Beach, Florida, 33410
About this study
Official title: CSP #512 - Options in Management With Anti-Retrovirals (OPTIMA), Management of Patients With HIV Infection for Whom First and Second-line Highly Active Anti-Retroviral Therapy Has Failed
This 'pragmatic' trial is a 2X2 open randomized study of patients in advanced HIV disease who have failed on conventional Highly Active Antiretroviral Therapy (HAART) regimens including all three classes of anti-HIV drugs. The first randomization will allocate patients to an intended 3-month antiretroviral drug-free period (ARDFP) or No ARDFP. The second randomization will allocate patients to Mega-ART (5+ drugs) or to Standard-ART (up to 4 drugs). The total study duration is 6.5 years with 5 years of intake and 1.5 year (minimum) of follow-up; median duration of patient follow-up is about 4 years. The target sample size is 390 patients and will provide 75% power to detect a 30% reduction in the hazard rate for the primary endpoint with mega-ART. Sixty-four sites will be participating in the trial--24 VA, 19 UK and 21 Canada.
Read the detailed description
Primary Hypothesis:
Compared to patients in Standard Antiretroviral Therapy (ART), patients in Mega-ART assuming full compliance, will experience a 30% reduction in the hazard of reaching a clinical endpoint (AIDS event or death).
Secondary Hypotheses:
Time to development of a new, non-HIV related serious adverse event, health related quality of life, the incidence of grade 3 or 4 clinical or laboratory adverse events and changes in virological and immunological markers (CD4 cell count, viral load, resistance profiles) will vary between the different treatment strategies.
Interventions:
Eligible patients will be randomized to one of four treatment strategy arms:
- No Antiretroviral Drug-Free Period (No ARDFP) and Standard-ART
- No Antiretroviral Drug-Free Period (No ARDFP) and Mega-ART
- Antiretroviral Drug-Free Period (ARDFP) and Standard-ART
- Antiretroviral Drug-Free Period (ARDFP) and Mega-ART
Note: The 'first' randomization will be ARDFP vs No ARDFP. Patients randomized to No ARDFP will receive their 'second' randomization at the same time. However, patients randomized to an Antiretroviral Drug Free Period (ARDFP) will receive their 'second' randomized assignment (Standard or Mega-ART) at the end of the ARDFP.
Note: All Serious Adverse Events were coded using the MedDRA coding dictionary; other (not serious) Adverse Events were collected as part of the study but were not coded using MedDRA or any other standardized coding dictionary.
This is the first trial of a Tri-National collaboration effort between the UK MRC, the Canadian CIHR and the VA CSP. The OPTIMA Trial was reviewed and approved by CSEC on October 12, 2000. The pre-kickoff meeting was held on March 21, 2001 in Washington, DC. The VA study kickoff meeting was held in Dallas, TX on May 16-18, 2001 and the Canadian kickoff was held in Toronto on May 29, 2001. The UK will have individual site initiation. As of October 17, 2005 there have been 357 patients enrolled in OPTIMA, at 64 sites in the three countries (279 in the VA, 41 in Canada and 37 in the UK). To date there are 64 sites actively participating in the study (24 in the VA, 19 in UK and 21 in Canada). Last date of patient follow-up was December 31, 2007.
- Conditions
- AIDS, HIV Infections
- Being tested
- No Antiretroviral Drug-Free Period (No ARDFP) vs ARDFP, Standard ART vs Mega ART
- Keywords
- AIDS, antiretrovirals, ART, drug-free period, HAART, HIV, human immunodeficiency virus, randomized, structured treatment interruptions
- Medical subject headings
- Acquired Immunodeficiency Syndrome, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Antiretroviral Drug-Free Period (No ARDFP) vs ARDFPOther
Continuation or interruption of ART treatment
Standard ART vs Mega ARTDrug
Standard therapy vs Intensified therapy
No Antiretroviral Drug-Free Period (No ARDFP) vs ARDFPOther
Continuation or interruption of ART treatment
Standard ART vs Mega ARTDrug
Standard therapy vs Intensified therapy
No Antiretroviral Drug-Free Period (No ARDFP) vs ARDFPOther
Continuation or interruption of ART treatment
Standard ART vs Mega ARTDrug
Standard therapy vs Intensified therapy
No Antiretroviral Drug-Free Period (No ARDFP) vs ARDFPOther
Continuation or interruption of ART treatment
Standard ART vs Mega ARTDrug
Standard therapy vs Intensified therapy
| Study group | Role | What they receive |
|---|---|---|
| No ARDFP+Standard-ART | Active comparator | No Antiretroviral Drug-Free Period (No ARDFP) and Standard-ART Receives: Other: No Antiretroviral Drug-Free Period (No ARDFP) vs ARDFP; Drug: Standard ART vs Mega ART |
| No ARDFP+Mega-ART | Active comparator | No Antiretroviral Drug-Free Period (No ARDFP) and Mega-ART Receives: Other: No Antiretroviral Drug-Free Period (No ARDFP) vs ARDFP; Drug: Standard ART vs Mega ART |
| ARDFP+Standard-ART | Active comparator | Antiretroviral Drug-Free Period (ARDFP) and Standard-ART Receives: Other: No Antiretroviral Drug-Free Period (No ARDFP) vs ARDFP; Drug: Standard ART vs Mega ART |
| ARDFP+Mega-ART | Active comparator | Antiretroviral Drug-Free Period (ARDFP) and Mega-ART Receives: Other: No Antiretroviral Drug-Free Period (No ARDFP) vs ARDFP; Drug: Standard ART vs Mega ART |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With New or Recurrent AIDS Event, or Death
New or recurrent AIDS event or Death were compared between Standard-ART (standard) and Mega-ART (intensification)
Measured: From date of randomization until onset of primary outcome or end of study follow-up (12/31/2007) whichever occured first, up to 6.5 years
Number of Participants With New or Recurrent AIDS Event, or Death
New or recurrent AIDS event or Death were compared between No ARDFP (continuation) and ARDFP (interruption)
Measured: From date of randomization until onset of primary outcome or end of study follow-up (12/31/2007) whichever occured first, up to 6.5 years
Number of Participants With New or Recurrent AIDS Event, or Death
New or recurrent AIDS event or Death were compared between No ARDFP (continuation)+Standard-ART (standard), No ARDFP (continuation)+Mega-ART (intensification), ARDFP (interruption)+Standard-ART (standard) and ARDFP (interruption)+Mega-ART (intensification)
Measured: From date of randomization until onset of primary outcome or end of study follow-up (12/31/2007) whichever occured first, up to 6.5 years
Secondary outcomes (2)
Number of Participants With a New, Non-HIV Related Serious Adverse Event
New, on-study non-HIV related Serious Adverse events were compared between Standard-ART (standard) and Mega-ART (intensification)
Measured: From date of randomization until onset of secondary outcome or end of study follow-up (12/31/2007) whichever occured first, up to 6.5 years
Number of Participants With New, Non-HIV Related Serious Adverse Event
New, on-study non-HIV related Serious Adverse events were compared between ARDFP (interruption) and No ARDFP (continuation)
Measured: From date of randomization until onset of secondary outcome or end of study follow-up (12/31/2007) whichever occured first, up to 6.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2002 (estimated)
- Study startJan 2001
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for AIDSStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 368 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Collaborators
- Medical Research Council, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Sheldon Brown, Study chair, VA Medical Center, Bronx
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00050089
- Sponsor's protocol ID
- 512
- Acronym
- OPTIMA
- Status last verified
- Apr 2015
- First submitted
- 20 Nov 2002
- Last updated
- 23 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kyriakides TC, Babiker A, Singer J, Cameron W, Schechter MT, Holodniy M, Brown ST, Youle M, Gazzard B; OPTIMA Study Team. An open-label randomized clinical trial of novel therapeutic strategies for HIV-infected patients in whom antiretroviral therapy has failed: rationale and design of the OPTIMA Trial. Control Clin Trials. 2003 Aug;24(4):481-500. doi: 10.1016/s0197-2456(03)00029-1.
PubMed 12865041Bedimo R, Kyriakides T, Brown S, Weidler J, Lie Y, Coakley E, Holodniy M. Predictive value of HIV-1 replication capacity and phenotypic susceptibility scores in antiretroviral treatment-experienced patients. HIV Med. 2012 Jul;13(6):345-51. doi: 10.1111/j.1468-1293.2011.00981.x. Epub 2012 Jan 26.
PubMed 22276745Kyriakides TC, Babiker A, Singer J, Piaseczny M, Russo J. Study conduct, monitoring and data management in a trinational trial: the OPTIMA model. Clin Trials. 2004;1(3):277-81. doi: 10.1191/1740774504cn022oa.
PubMed 16279253Dau B, Ayers D, Singer J, Harrigan PR, Brown S, Kyriakides T, Cameron DW, Angus B, Holodniy M. Connection domain mutations in treatment-experienced patients in the OPTIMA trial. J Acquir Immune Defic Syndr. 2010 Jun;54(2):160-6. doi: 10.1097/QAI.0b013e3181cbd235.
PubMed 20130473Bansback N, Sun H, Guh DP, Li X, Nosyk B, Griffin S, Barnett PG, Anis AH; OPTIMA TEAM. Impact of the recall period on measuring health utilities for acute events. Health Econ. 2008 Dec;17(12):1413-9. doi: 10.1002/hec.1351.
PubMed 18404664Desai S, Kyriakides T, Holodniy M, Al-Salman J, Griffith B, Kozal M. Evolution of genotypic resistance algorithms and their impact on the interpretation of clinical trials: an OPTIMA trial substudy. HIV Clin Trials. 2007 Sep-Oct;8(5):293-302. doi: 10.1310/hct0805-293.
PubMed 17956830Barnett PG, Chow A, Joyce VR, Bayoumi AM, Griffin SC, Nosyk B, Holodniy M, Brown ST, Sculpher M, Anis AH, Owens DK. Determinants of the cost of health services used by veterans with HIV. Med Care. 2011 Sep;49(9):848-56. doi: 10.1097/MLR.0b013e31821b34c0.
PubMed 21610542Nosyk B, Sun H, Bansback N, Guh DP, Li X, Barnett P, Bayoumi A, Griffin S, Joyce V, Holodniy M, Owens DK, Anis AH. The concurrent validity and responsiveness of the health utilities index (HUI 3) among patients with advanced HIV/AIDS. Qual Life Res. 2009 Sep;18(7):815-24. doi: 10.1007/s11136-009-9504-0. Epub 2009 Jun 27.
PubMed 19562514Anis AH, Nosyk B, Sun H, Guh DP, Bansback N, Li X, Barnett PG, Joyce V, Swanson KM, Kyriakides TC, Holodniy M, Cameron DW, Brown ST; OPTIMA Team1. Quality of life of patients with advanced HIV/AIDS: measuring the impact of both AIDS-defining events and non-AIDS serious adverse events. J Acquir Immune Defic Syndr. 2009 Aug 15;51(5):631-9. doi: 10.1097/QAI.0b013e3181a4f00d.
PubMed 19430303Joyce VR, Barnett PG, Bayoumi AM, Griffin SC, Kyriakides TC, Yu W, Sundaram V, Holodniy M, Brown ST, Cameron W, Youle M, Sculpher M, Anis AH, Owens DK. Health-related quality of life in a randomized trial of antiretroviral therapy for advanced HIV disease. J Acquir Immune Defic Syndr. 2009 Jan 1;50(1):27-36. doi: 10.1097/QAI.0b013e31818ce6f3.
PubMed 19295332Joyce VR, Barnett PG, Chow A, Bayoumi AM, Griffin SC, Sun H, Holodniy M, Brown ST, Kyriakides TC, Cameron DW, Youle M, Sculpher M, Anis AH, Owens DK. Effect of treatment interruption and intensification of antiretroviral therapy on health-related quality of life in patients with advanced HIV: a randomized, controlled trial. Med Decis Making. 2012 Jan-Feb;32(1):70-82. doi: 10.1177/0272989X10397615. Epub 2011 Mar 7.
PubMed 21383086Holodniy M, Brown ST, Cameron DW, Kyriakides TC, Angus B, Babiker A, Singer J, Owens DK, Anis A, Goodall R, Hudson F, Piaseczny M, Russo J, Schechter M, Deyton L, Darbyshire J; OPTIMA Team. Results of antiretroviral treatment interruption and intensification in advanced multi-drug resistant HIV infection from the OPTIMA trial. PLoS One. 2011 Mar 31;6(3):e14764. doi: 10.1371/journal.pone.0014764.
PubMed 21483491
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSP #512 - Options in Management With Anti-Retrovirals (OPTIMA), Management of Patients With HIV Infection for Whom First and Second-line Highly Active Anti-Retroviral Therapy Has Failed
- ClinicalTrials.gov ID
- NCT00050089
- Acronym / sponsor ID
- OPTIMA / 512
- Conditions
- AIDS, HIV Infections
- Keywords
- AIDS, antiretrovirals, ART, drug-free period, HAART, HIV, human immunodeficiency virus, randomized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 368 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Collaborators
- Medical Research Council, Canadian Institutes of Health Research (CIHR)
- Study start
- Jan 2001
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 22 Nov 2002 (estimated)
- Results
- Posted 13 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This 'pragmatic' trial is a 2X2 open randomized study of patients in advanced HIV disease who have failed on conventional Highly Active Antiretroviral Therapy (HAART) regimens including all three classes of anti-HIV drugs. The first randomization will allocate patients to an intended 3-month antiretroviral drug-free period (ARDFP) or No ARDFP. The second randomization will allocate patients to Mega-ART (5+ drugs) or to Standard-ART (up to 4 drugs). The total study duration is 6.5 years with 5 years of intake and 1.5 year (minimum) of follow-up; median duration of patient follow-up is about 4 years. The target sample size is 390 patients and will provide 75% power to detect a 30% reduction in the hazard rate for the primary endpoint with mega-ART. Sixty-four sites will be participating in the trial--24 VA, 19 UK and 21 Canada.
Detailed description
Primary Hypothesis:
Compared to patients in Standard Antiretroviral Therapy (ART), patients in Mega-ART assuming full compliance, will experience a 30% reduction in the hazard of reaching a clinical endpoint (AIDS event or death).
Secondary Hypotheses:
Time to development of a new, non-HIV related serious adverse event, health related quality of life, the incidence of grade 3 or 4 clinical or laboratory adverse events and changes in virological and immunological markers (CD4 cell count, viral load, resistance profiles) will vary between the different treatment strategies.
Interventions:
Eligible patients will be randomized to one of four treatment strategy arms:
- No Antiretroviral Drug-Free Period (No ARDFP) and Standard-ART
- No Antiretroviral Drug-Free Period (No ARDFP) and Mega-ART
- Antiretroviral Drug-Free Period (ARDFP) and Standard-ART
- Antiretroviral Drug-Free Period (ARDFP) and Mega-ART
Note: The 'first' randomization will be ARDFP vs No ARDFP. Patients randomized to No ARDFP will receive their 'second' randomization at the same time. However, patients randomized to an Antiretroviral Drug Free Period (ARDFP) will receive their 'second' randomized assignment (Standard or Mega-ART) at the end of the ARDFP.
Note: All Serious Adverse Events were coded using the MedDRA coding dictionary; other (not serious) Adverse Events were collected as part of the study but were not coded using MedDRA or any other standardized coding dictionary.
This is the first trial of a Tri-National collaboration effort between the UK MRC, the Canadian CIHR and the VA CSP. The OPTIMA Trial was reviewed and approved by CSEC on October 12, 2000. The pre-kickoff meeting was held on March 21, 2001 in Washington, DC. The VA study kickoff meeting was held in Dallas, TX on May 16-18, 2001 and the Canadian kickoff was held in Toronto on May 29, 2001. The UK will have individual site initiation. As of October 17, 2005 there have been 357 patients enrolled in OPTIMA, at 64 sites in the three countries (279 in the VA, 41 in Canada and 37 in the UK). To date there are 64 sites actively participating in the study (24 in the VA, 19 in UK and 21 in Canada). Last date of patient follow-up was December 31, 2007.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No ARDFP+Standard-ART | Active comparator | Other: No Antiretroviral Drug-Free Period (No ARDFP) vs ARDFP, Drug: Standard ART vs Mega ARTNo Antiretroviral Drug-Free Period (No ARDFP) and Standard-ART |
| No ARDFP+Mega-ART | Active comparator | Other: No Antiretroviral Drug-Free Period (No ARDFP) vs ARDFP, Drug: Standard ART vs Mega ARTNo Antiretroviral Drug-Free Period (No ARDFP) and Mega-ART |
| ARDFP+Standard-ART | Active comparator | Other: No Antiretroviral Drug-Free Period (No ARDFP) vs ARDFP, Drug: Standard ART vs Mega ARTAntiretroviral Drug-Free Period (ARDFP) and Standard-ART |
| ARDFP+Mega-ART | Active comparator | Other: No Antiretroviral Drug-Free Period (No ARDFP) vs ARDFP, Drug: Standard ART vs Mega ARTAntiretroviral Drug-Free Period (ARDFP) and Mega-ART |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ability to provide informed consent
- Age of 18 years or more
- Serologic or virologic diagnosis of HIV infection
- Failure of at least two different multi-drug regimens that include drugs of all 3 classes that the patient can tolerate or laboratory evidence of resistance to drugs in each of the 3 classes
- Had at least 3 months of current ART and are still on treatment
Key exclusion criteria (4 listed)
- Pregnancy, breast-feeding or planned pregnancy
- Likelihood of poor protocol follow-up or if Mega-Art is not feasible (due to significant intolerance of many ARV drugs)
- Serious, uncontrolled major opportunistic infection (OI) within 14 days of screening
- Likelihood of early death due to non-HIV disease
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 |
|---|---|---|
| No Antiretroviral Drug-Free Period (No ARDFP) vs ARDFPContinuation or interruption of ART treatment | Other | No ARDFP+Standard-ART |
| Standard ART vs Mega ARTStandard therapy vs Intensified therapy | Drug | No ARDFP+Standard-ART |
| No Antiretroviral Drug-Free Period (No ARDFP) vs ARDFPContinuation or interruption of ART treatment | Other | No ARDFP+Mega-ART |
| Standard ART vs Mega ARTStandard therapy vs Intensified therapy | Drug | No ARDFP+Mega-ART |
| No Antiretroviral Drug-Free Period (No ARDFP) vs ARDFPContinuation or interruption of ART treatment | Other | ARDFP+Standard-ART |
| Standard ART vs Mega ARTStandard therapy vs Intensified therapy | Drug | ARDFP+Standard-ART |
| No Antiretroviral Drug-Free Period (No ARDFP) vs ARDFPContinuation or interruption of ART treatment | Other | ARDFP+Mega-ART |
| Standard ART vs Mega ARTStandard therapy vs Intensified therapy | Drug | ARDFP+Mega-ART |
Primary outcome
Number of Participants With New or Recurrent AIDS Event, or Death
Time frame: From date of randomization until onset of primary outcome or end of study follow-up (12/31/2007) whichever occured first, up to 6.5 years
New or recurrent AIDS event or Death were compared between Standard-ART (standard) and Mega-ART (intensification)
Number of Participants With New or Recurrent AIDS Event, or Death
Time frame: From date of randomization until onset of primary outcome or end of study follow-up (12/31/2007) whichever occured first, up to 6.5 years
New or recurrent AIDS event or Death were compared between No ARDFP (continuation) and ARDFP (interruption)
Number of Participants With New or Recurrent AIDS Event, or Death
Time frame: From date of randomization until onset of primary outcome or end of study follow-up (12/31/2007) whichever occured first, up to 6.5 years
New or recurrent AIDS event or Death were compared between No ARDFP (continuation)+Standard-ART (standard), No ARDFP (continuation)+Mega-ART (intensification), ARDFP (interruption)+Standard-ART (standard) and ARDFP (interruption)+Mega-ART (intensification)
2 secondary outcomes
Number of Participants With a New, Non-HIV Related Serious Adverse Event
Time frame: From date of randomization until onset of secondary outcome or end of study follow-up (12/31/2007) whichever occured first, up to 6.5 years
Number of Participants With New, Non-HIV Related Serious Adverse Event
Time frame: From date of randomization until onset of secondary outcome or end of study follow-up (12/31/2007) whichever occured first, up to 6.5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12865041Kyriakides TC, Babiker A, Singer J, Cameron W, Schechter MT, Holodniy M, Brown ST, Youle M, Gazzard B; OPTIMA Study Team. An open-label randomized clinical trial of novel therapeutic strategies for HIV-infected patients in whom antiretroviral therapy has failed: rationale and design of the OPTIMA Trial. Control Clin Trials. 2003 Aug;24(4):481-500. doi: 10.1016/s0197-2456(03)00029-1.
- Background: PubMed 22276745Bedimo R, Kyriakides T, Brown S, Weidler J, Lie Y, Coakley E, Holodniy M. Predictive value of HIV-1 replication capacity and phenotypic susceptibility scores in antiretroviral treatment-experienced patients. HIV Med. 2012 Jul;13(6):345-51. doi: 10.1111/j.1468-1293.2011.00981.x. Epub 2012 Jan 26.
- Background: PubMed 16279253Kyriakides TC, Babiker A, Singer J, Piaseczny M, Russo J. Study conduct, monitoring and data management in a trinational trial: the OPTIMA model. Clin Trials. 2004;1(3):277-81. doi: 10.1191/1740774504cn022oa.
- Background: PubMed 20130473Dau B, Ayers D, Singer J, Harrigan PR, Brown S, Kyriakides T, Cameron DW, Angus B, Holodniy M. Connection domain mutations in treatment-experienced patients in the OPTIMA trial. J Acquir Immune Defic Syndr. 2010 Jun;54(2):160-6. doi: 10.1097/QAI.0b013e3181cbd235.
- Background: PubMed 18404664Bansback N, Sun H, Guh DP, Li X, Nosyk B, Griffin S, Barnett PG, Anis AH; OPTIMA TEAM. Impact of the recall period on measuring health utilities for acute events. Health Econ. 2008 Dec;17(12):1413-9. doi: 10.1002/hec.1351.
- Background: PubMed 17956830Desai S, Kyriakides T, Holodniy M, Al-Salman J, Griffith B, Kozal M. Evolution of genotypic resistance algorithms and their impact on the interpretation of clinical trials: an OPTIMA trial substudy. HIV Clin Trials. 2007 Sep-Oct;8(5):293-302. doi: 10.1310/hct0805-293.
- Results publication: PubMed 21610542Barnett PG, Chow A, Joyce VR, Bayoumi AM, Griffin SC, Nosyk B, Holodniy M, Brown ST, Sculpher M, Anis AH, Owens DK. Determinants of the cost of health services used by veterans with HIV. Med Care. 2011 Sep;49(9):848-56. doi: 10.1097/MLR.0b013e31821b34c0.
- Results publication: PubMed 19562514Nosyk B, Sun H, Bansback N, Guh DP, Li X, Barnett P, Bayoumi A, Griffin S, Joyce V, Holodniy M, Owens DK, Anis AH. The concurrent validity and responsiveness of the health utilities index (HUI 3) among patients with advanced HIV/AIDS. Qual Life Res. 2009 Sep;18(7):815-24. doi: 10.1007/s11136-009-9504-0. Epub 2009 Jun 27.
- Results publication: PubMed 19430303Anis AH, Nosyk B, Sun H, Guh DP, Bansback N, Li X, Barnett PG, Joyce V, Swanson KM, Kyriakides TC, Holodniy M, Cameron DW, Brown ST; OPTIMA Team1. Quality of life of patients with advanced HIV/AIDS: measuring the impact of both AIDS-defining events and non-AIDS serious adverse events. J Acquir Immune Defic Syndr. 2009 Aug 15;51(5):631-9. doi: 10.1097/QAI.0b013e3181a4f00d.
- Results publication: PubMed 19295332Joyce VR, Barnett PG, Bayoumi AM, Griffin SC, Kyriakides TC, Yu W, Sundaram V, Holodniy M, Brown ST, Cameron W, Youle M, Sculpher M, Anis AH, Owens DK. Health-related quality of life in a randomized trial of antiretroviral therapy for advanced HIV disease. J Acquir Immune Defic Syndr. 2009 Jan 1;50(1):27-36. doi: 10.1097/QAI.0b013e31818ce6f3.
- Results publication: PubMed 21383086Joyce VR, Barnett PG, Chow A, Bayoumi AM, Griffin SC, Sun H, Holodniy M, Brown ST, Kyriakides TC, Cameron DW, Youle M, Sculpher M, Anis AH, Owens DK. Effect of treatment interruption and intensification of antiretroviral therapy on health-related quality of life in patients with advanced HIV: a randomized, controlled trial. Med Decis Making. 2012 Jan-Feb;32(1):70-82. doi: 10.1177/0272989X10397615. Epub 2011 Mar 7.
- Derived from this study: PubMed 21483491Holodniy M, Brown ST, Cameron DW, Kyriakides TC, Angus B, Babiker A, Singer J, Owens DK, Anis A, Goodall R, Hudson F, Piaseczny M, Russo J, Schechter M, Deyton L, Darbyshire J; OPTIMA Team. Results of antiretroviral treatment interruption and intensification in advanced multi-drug resistant HIV infection from the OPTIMA trial. PLoS One. 2011 Mar 31;6(3):e14764. doi: 10.1371/journal.pone.0014764.
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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.
Sheldon Brown study chair
VA Medical Center, Bronx
30 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No Antiretroviral Drug-Free Period (No ARDFP) vs ARDFP and Standard ART vs Mega ART in people with AIDS and HIV Infections, run by US Department of Veterans Affairs at 30 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 6 inclusion and 4 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 23 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With New or Recurrent AIDS Event, or Death (time frame: From date of randomization until onset of primary outcome or end of study follow-up (12/31/2007) whichever occured first, up to 6.5 years). The study lists 3 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 NCT00050089, which also lists 12 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 23 Apr 2015.