Trial · NCT01083810
Evaluation of Kaletra Therapy Over the Long-term
NCT01083810, Completed, Abbott; results first posted 2011-07-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluation of Kaletra Therapy Over the Long-term. Trials, record NCT01083810. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01083810
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Kaletra Therapy Over the Long-term
- NCT number
- NCT01083810
- Status
- Completed
- Enrollment
- 284 participants, actual
- Lead sponsor
- Abbott
- Conditions
- Human Immunodeficiency Virus
- Interventions
- Lopinavir/Ritonavir (Kaletra)
- First posted
- 2010-03-10
- Last updated
- 2011-08-11
- Results first posted
- 2011-07-29
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs | Baseline and at any timepoint where testing is possible | Standard genotypic resistance assays were developed for HIV-1 viral load levels greater than 500 to 1000 copies per milliliter (mL). All 3 protocols recommended this testing be done at Baseline prior to lopinavir/ritonavir therapy and (if possible) in cases of virologic failure. The exact timing varied and depended on whether there was an adequate viral load and physician clinical judgment. Participants with resistance to lopinavir/ritonavir, nucleoside reverse transcriptase inhibitors (NRTI) or non-nucleoside reverse transcriptase inhibitors (NNRTI) at Baseline and follow-up are reported. |
| Secondary | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks | All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with HIV-1 ribonucleic acid (RNA) less than 50 copies/mL at each time point is presented by subgroup. |
| Secondary | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks | All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with HIV-1 RNA levels of 50 to less than 200 copies/mL at each time point is presented by subgroup. |
| Secondary | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks | All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with HIV-1 RNA levels of 200 to less than 500 copies/mL at each time point is presented by subgroup. |
| Secondary | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks | All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with more than 500 HIV-1 RNA copies/mL at each time point is presented by subgroup. |
| Secondary | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks | The evolution of participants' CD4-positive (CD4+) T-lymphocyte counts after starting the lopinavir/ritonavir-containing regimen was to be assessed by measuring the number of CD4+ cells at baseline and each subsequent study visit. Study visits were to occur at approximately Weeks 4, 12, 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. CD4+ cell count results are reported as the change from Baseline in the absolute number of CD4+ cells per microliter. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs | Baseline and at any timepoint where testing is possible | All participants with resistance testing at baseline and follow-up are presented. | Participants | NUMBER |
| SECONDARY | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks | All participants with HIV-1 RNA measurements at Baseline and any subsequent time point are presented, including those who discontinued due to virologic failure. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks | All participants with HIV-1 RNA measurements at Baseline and any subsequent time point are presented, including those who discontinued due to virologic failure. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks | All participants with HIV-1 RNA measurements at Baseline and any subsequent time point are presented, including those who discontinued due to virologic failure. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks | All participants with HIV-1 RNA measurements at Baseline and any subsequent time point are presented, including those who discontinued due to virologic failure. | Percentage of participants | NUMBER |
| SECONDARY | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks | All participants with CD4+ measurements at Baseline and any subsequent time point are included. | CD4+ cells/µL | MEAN |
Source ClinicalTrials.gov
Results by group360
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs | Therapy-naive | Genotypic resistance testing performed at Baseline | 137 | Participants | |
| Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs | Pre-treated | Genotypic resistance testing performed at Baseline | 68 | Participants | |
| Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs | Non-B | Genotypic resistance testing performed at Baseline | 55 | Participants | |
| Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs | Therapy-naive | Complete resistance testing results at Baseline | 122 | Participants | |
| Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs | Pre-treated | Complete resistance testing results at Baseline | 68 | Participants | |
| Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs | Non-B | Complete resistance testing results at Baseline | 55 | Participants | |
| Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs | Therapy-naive | >Resistance to lopinavir/ritonavir at Baseline | 0 | Participants | |
| Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs | Pre-treated | >Resistance to lopinavir/ritonavir at Baseline | 2 | Participants | |
| Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs | Non-B | >Resistance to lopinavir/ritonavir at Baseline | 0 | Participants | |
| Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs | Therapy-naive | >Partial resistance to NRTI at Baseline | 5 | Participants |
1 to 10 of 360Source ClinicalTrials.gov
See all 360 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Therapy-naive | 137 | |
| Overall Study | STARTED | Pre-treated | 92 | |
| Overall Study | STARTED | Non-B | 55 | |
| Overall Study | COMPLETED | Therapy-naive | 72 | |
| Overall Study | COMPLETED | Pre-treated | 47 | |
| Overall Study | COMPLETED | Non-B | 35 | |
| Overall Study | NOT COMPLETED | Therapy-naive | 65 | |
| Overall Study | NOT COMPLETED | Pre-treated | 45 | |
| Overall Study | NOT COMPLETED | Non-B | 20 |
Source ClinicalTrials.gov
Adverse events48
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhea | Gastrointestinal disorders | HIV-infected Patients | 40 | 284 | 42 |
| other | Nausea | Gastrointestinal disorders | HIV-infected Patients | 16 | 284 | 16 |
| serious | Diarrhea | Gastrointestinal disorders | HIV-infected Patients | 2 | 284 | 2 |
| serious | Nausea | Gastrointestinal disorders | HIV-infected Patients | 1 | 284 | 1 |
| serious | Vomiting | Gastrointestinal disorders | HIV-infected Patients | 1 | 284 | 1 |
| serious | Weight loss | Metabolism and nutrition disorders | HIV-infected Patients | 1 | 284 | 1 |
| serious | Ataxia left leg | Nervous system disorders | HIV-infected Patients | 1 | 284 | 1 |
| serious | Paralysis left upper extremity | Nervous system disorders | HIV-infected Patients | 1 | 284 | 1 |
| serious | Paralysis of left side of face | Nervous system disorders | HIV-infected Patients | 1 | 284 | 1 |
| serious | Fall | Nervous system disorders | HIV-infected Patients | 1 | 284 | 1 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | HIV-infected Patients | ||
| Total, other adverse events | HIV-infected Patients | 56 | 284 |
| Total, serious adverse events | HIV-infected Patients | 16 | 284 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01083810
GET https://conductscience.org/api/trials/v1/NCT01083810/results?page=2