Optimizing Treatment for Treatment-Experienced, HIV-Infected People
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ClinicalTrials.gov Identifier: NCT00537394 |
Recruitment Status :
Completed
First Posted : October 1, 2007
Results First Posted : August 7, 2014
Last Update Posted : May 26, 2016
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Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator:
AIDS Clinical Trials Group
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
HIV Infections |
Interventions |
Drug: Enfuvirtide Drug: Raltegravir Drug: Darunavir Drug: Tipranavir Drug: Etravirine Drug: Maraviroc |
Enrollment | 517 |
Participant Flow
Recruitment Details | Subjects recruited between February 2008 and May 2011 from participating ACTG, IMPAACT, and ATN network sites located in the continental US and Puerto Rico. |
Pre-assignment Details | A total of 104 exclusions among 517 enrolled to active screening but prior to assignment and dispensation of study treatment were due to any of the following: no resistance/tropism test results, not willing to accept any ARV study regimens, changes to current PI based ARV regimen or non-adherence, or changes with respect to eligibility criteria. |
Arm/Group Title | Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0) | Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2) | Non-randomized Group: Add NRTIs to Individual Regimen cPSS <=2 |
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[Arm A]Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started. | [Arm B] Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued. | [Non-randomized Group C] : Among persons whose ARV resistance and history profile precluded any of the 20 possible ARV regimens having high enough potential potency (cPSS <=2), treatment was assigned rather than being a randomized. To their regimen, individualized NRTI combination of at least 2 drugs from this class were added in order to form the most potent ARV regimen possible. |
Period Title: First Year of Follow-up | |||
Started | 181 | 179 | 53 |
Completed | 169 [1] | 168 [1] | 50 |
Not Completed | 12 | 11 | 3 |
Reason Not Completed | |||
Death | 7 | 0 | 0 |
Severe debilitation | 1 | 0 | 1 |
Withdrawal by Subject | 3 | 6 | 1 |
Lost to Follow-up | 1 | 5 | 1 |
[1]
Completed refers to completing first 48 weeks of follow-up.
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Period Title: 2nd Year of Follow-up | |||
Started | 169 | 168 | 50 |
Completed | 158 | 159 | 44 |
Not Completed | 11 | 9 | 6 |
Reason Not Completed | |||
Death | 4 | 1 | 2 |
Withdrawal by Subject | 0 | 1 | 2 |
Lost to Follow-up | 6 | 7 | 2 |
Clinic site closure | 1 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0) | Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2) | Non-randomized Group: Add NRTIs to Individual Regimen cPSS <=2 | Total | |
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Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started. | Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued. | Among persons whose ARV resistance and history profile precluded any of the 20 possible ARV regimens having high enough potential potency (cPSS <=2), treatment was assigned rather than being a randomized. To their regimen, individualized NRTI combination of at least 2 drugs from this class were added in order to form the most potent ARV regimen possible. | Total of all reporting groups | |
Overall Number of Baseline Participants | 181 | 179 | 53 | 413 | |
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Everyone randomized (ITT study sample), plus non-randomized group.
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 181 participants | 179 participants | 53 participants | 413 participants | |
<=18 years |
6 3.3%
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8 4.5%
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3 5.7%
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17 4.1%
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Between 18 and 65 years |
173 95.6%
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168 93.9%
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50 94.3%
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391 94.7%
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>=65 years |
2 1.1%
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3 1.7%
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0 0.0%
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5 1.2%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 181 participants | 179 participants | 53 participants | 413 participants | |
44.7 (10.8) | 44.1 (11.7) | 43.1 (10.7) | 44.3 (11.2) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 181 participants | 179 participants | 53 participants | 413 participants | |
Female |
46 25.4%
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47 26.3%
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6 11.3%
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99 24.0%
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Male |
135 74.6%
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132 73.7%
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47 88.7%
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314 76.0%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 181 participants | 179 participants | 53 participants | 413 participants | |
Hispanic or Latino |
37 20.4%
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46 25.7%
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14 26.4%
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97 23.5%
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Not Hispanic or Latino |
141 77.9%
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132 73.7%
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38 71.7%
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311 75.3%
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Unknown or Not Reported |
3 1.7%
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1 0.6%
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1 1.9%
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5 1.2%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 181 participants | 179 participants | 53 participants | 413 participants | |
American Indian or Alaska Native |
3 1.7%
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2 1.1%
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1 1.9%
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6 1.5%
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Asian |
0 0.0%
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4 2.2%
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1 1.9%
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5 1.2%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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1 0.6%
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0 0.0%
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1 0.2%
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Black or African American |
81 44.8%
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72 40.2%
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20 37.7%
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173 41.9%
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White |
88 48.6%
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87 48.6%
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29 54.7%
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204 49.4%
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More than one race |
1 0.6%
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2 1.1%
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0 0.0%
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3 0.7%
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Unknown or Not Reported |
8 4.4%
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11 6.1%
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2 3.8%
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21 5.1%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 181 participants | 179 participants | 53 participants | 413 participants |
181 | 179 | 53 | 413 | ||
CD4 count, continuous
Mean (Standard Deviation) Unit of measure: Cells/mm^3 |
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Number Analyzed | 181 participants | 179 participants | 53 participants | 413 participants | |
252.3 (194.9) | 245.6 (195.1) | 154.8 (170.1) | 236.9 (194.2) | ||
Plasma HIV-1 RNA, continuous
Median (Inter-Quartile Range) Unit of measure: Log10 copies/mL |
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Number Analyzed | 181 participants | 179 participants | 53 participants | 413 participants | |
4.2
(3.6 to 4.7)
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4.2
(3.6 to 4.6)
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4.4
(4.1 to 4.8)
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4.2
(3.6 to 4.6)
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.
Results Point of Contact
Name/Title: | ACTG Clinicaltrials.gov Coordinator |
Organization: | ACTG Network Coordinating Center, Social & Scientific Systems, Inc. |
Phone: | (301)628-3313 |
EMail: | ACTGCT.Gov@s-3.com |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00537394 |
Other Study ID Numbers: |
A5241 10395 ( Registry Identifier: DAIDS ES ) ACTG A5241 OPTIONS |
First Submitted: | September 27, 2007 |
First Posted: | October 1, 2007 |
Results First Submitted: | June 14, 2013 |
Results First Posted: | August 7, 2014 |
Last Update Posted: | May 26, 2016 |