Human Immunodeficiency Virus
Conditions
Keywords
Human Immunodeficiency Virus, Infection, Kaletra, Resistance, Mutations, alternative Therapy regimen
Brief summary
Long term observation of patients under lopinavir/ritonavir containing therapy
Detailed description
Three to five year observation of lopinavir/ritonavir therapy. Reporting groups are 1) therapy-naïve patients (144 weeks), 2) therapy-experienced but protease inhibitor naïve patients (240 weeks,) and 3) non-B subtype infected patients (240 weeks). These three groups of participants with HIV-1 infection were at first registered as three different studies: KAL1RO (this study, NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55) but were now reconciled under KAL1RO (NCT01083810) as a single study with three reporting groups.
Interventions
3 capsules 2xdaily or 2 tablets 2xdaily Kaletra
Sponsors
Abbott
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients infected by HIV-1 * Age greater than or equal to 18 years
Exclusion criteria
* as described in SmPC (summary of product characteristics) at the time of prescription
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Germany
Participant flow
Recruitment details
These three groups of participants with HIV-1 infection were at first registered as three different studies: KAL1RO (this study, NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55) but were now reconciled under KAL1RO (NCT01083810) as a single study with three reporting groups.
Participants by arm
| Arm | Count |
|---|---|
| Therapy-naive Participants who had not received prior antiretroviral drug therapy. | 137 |
| Pre-treated Participants that had previously received antiretroviral therapy, but were protease inhibitor naive. | 92 |
| Non-B Participants infected with non-B subtypes of HIV-1. | 55 |
| Total | 284 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 15 | 11 | 4 |
| Overall Study | Co-morbidities | 1 | 0 | 0 |
| Overall Study | Death | 2 | 2 | 3 |
| Overall Study | Lost to Follow-up | 23 | 11 | 4 |
| Overall Study | Non-compliance | 4 | 7 | 2 |
| Overall Study | Participation in study | 1 | 0 | 0 |
| Overall Study | Reason not reported | 6 | 1 | 1 |
| Overall Study | Simplification | 4 | 1 | 0 |
| Overall Study | Therapy break | 1 | 2 | 2 |
| Overall Study | Virologic failure | 1 | 8 | 0 |
| Overall Study | Withdrawal by Subject | 7 | 2 | 4 |
Baseline characteristics
| Characteristic | Therapy-naive | Pre-treated | Non-B | Total |
|---|---|---|---|---|
| Age, Customized >= 18 years of age (exact age not reported) | 137 Participants | 92 Participants | 55 Participants | 284 Participants |
| Region of Enrollment Germany | 137 participants | 92 participants | 55 participants | 284 participants |
| Sex/Gender, Customized Female | 17 Participants | 11 Participants | 20 Participants | 48 Participants |
| Sex/Gender, Customized Gender not reported | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Sex/Gender, Customized Male | 119 Participants | 81 Participants | 35 Participants | 235 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 56 / 284 |
| serious Total, serious adverse events | 16 / 284 |
Outcome results
Primary
Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs
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.
Time frame: Baseline and at any timepoint where testing is possible
Population: All participants with resistance testing at baseline and follow-up are presented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Therapy-naive | Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs | Genotypic resistance testing performed at Baseline | 137 Participants |
| Therapy-naive | Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs | Complete resistance testing results at Baseline | 122 Participants |
| Therapy-naive | Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs | >Resistance to lopinavir/ritonavir at Baseline | 0 Participants |
| Therapy-naive | Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs | >Partial resistance to NRTI at Baseline | 5 Participants |
| Therapy-naive | Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs | >Partial resistance to NNRTI at Baseline | 0 Participants |
| Therapy-naive | Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs | Underwent resistance testing at follow-up | 2 Participants |
| Therapy-naive | Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs | >Resistance to lopinavir/ritonavir* | 0 Participants |
| Therapy-naive | Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs | >>Resistance to NRTIs | 0 Participants |
| Therapy-naive | Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs | >>Resistance to NNRTIs | 0 Participants |
| Therapy-naive | Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs | *No baseline results avail for this participant | NA Participants |
| Pre-treated | Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs | Underwent resistance testing at follow-up | 2 Participants |
| Pre-treated | Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs | Genotypic resistance testing performed at Baseline | 68 Participants |
| Pre-treated | Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs | >Partial resistance to NNRTI at Baseline | 0 Participants |
| Pre-treated | Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs | *No baseline results avail for this participant | 1 Participants |
| Pre-treated | Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs | Complete resistance testing results at Baseline | 68 Participants |
| Pre-treated | Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs | >>Resistance to NNRTIs | 0 Participants |
| Pre-treated | Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs | >>Resistance to NRTIs | 1 Participants |
| Pre-treated | Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs | >Resistance to lopinavir/ritonavir at Baseline | 2 Participants |
| Pre-treated | Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs | >Resistance to lopinavir/ritonavir* | 1 Participants |
| Pre-treated | Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs | >Partial resistance to NRTI at Baseline | 0 Participants |
| Non-B | Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs | >>Resistance to NRTIs | 0 Participants |
| Non-B | Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs | >Partial resistance to NRTI at Baseline | 0 Participants |
| Non-B | Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs | *No baseline results avail for this participant | NA Participants |
| Non-B | Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs | >Partial resistance to NNRTI at Baseline | 0 Participants |
| Non-B | Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs | >>Resistance to NNRTIs | 0 Participants |
| Non-B | Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs | Underwent resistance testing at follow-up | 2 Participants |
| Non-B | Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs | >Resistance to lopinavir/ritonavir* | 0 Participants |
| Non-B | Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs | Genotypic resistance testing performed at Baseline | 55 Participants |
| Non-B | Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs | Complete resistance testing results at Baseline | 55 Participants |
| Non-B | Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs | >Resistance to lopinavir/ritonavir at Baseline | 0 Participants |
Secondary
Change in Absolute CD4 Cell Count [CD4+ Cells/µL]
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.
Time frame: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks
Population: All participants with CD4+ measurements at Baseline and any subsequent time point are included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Therapy-naive | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 96 | 296 CD4+ cells/µL | Standard Deviation 190 |
| Therapy-naive | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 48 | 240 CD4+ cells/µL | Standard Deviation 162 |
| Therapy-naive | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 168 | NA CD4+ cells/µL | — |
| Therapy-naive | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 108 | 329 CD4+ cells/µL | Standard Deviation 204 |
| Therapy-naive | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 228 | NA CD4+ cells/µL | — |
| Therapy-naive | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 156 | NA CD4+ cells/µL | — |
| Therapy-naive | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 120 | 316 CD4+ cells/µL | Standard Deviation 177 |
| Therapy-naive | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 36 | 211 CD4+ cells/µL | Standard Deviation 203 |
| Therapy-naive | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 144 | 292 CD4+ cells/µL | Standard Deviation 163 |
| Therapy-naive | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 132 | 313 CD4+ cells/µL | Standard Deviation 237 |
| Therapy-naive | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 4 | 140 CD4+ cells/µL | Standard Deviation 145 |
| Therapy-naive | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 216 | NA CD4+ cells/µL | — |
| Therapy-naive | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 12 | 146 CD4+ cells/µL | Standard Deviation 130 |
| Therapy-naive | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 204 | NA CD4+ cells/µL | — |
| Therapy-naive | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 60 | 266 CD4+ cells/µL | Standard Deviation 185 |
| Therapy-naive | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 240 | NA CD4+ cells/µL | — |
| Therapy-naive | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 192 | NA CD4+ cells/µL | — |
| Therapy-naive | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 72 | 248 CD4+ cells/µL | Standard Deviation 201 |
| Therapy-naive | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 24 | 193 CD4+ cells/µL | Standard Deviation 170 |
| Therapy-naive | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 180 | NA CD4+ cells/µL | — |
| Therapy-naive | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 84 | 295 CD4+ cells/µL | Standard Deviation 248 |
| Therapy-naive | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Baseline | 0 CD4+ cells/µL | Standard Deviation 0 |
| Pre-treated | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 168 | 190 CD4+ cells/µL | Standard Deviation 156 |
| Pre-treated | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Baseline | 0 CD4+ cells/µL | Standard Deviation 0 |
| Pre-treated | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 24 | 106 CD4+ cells/µL | Standard Deviation 209 |
| Pre-treated | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 36 | 144 CD4+ cells/µL | Standard Deviation 203 |
| Pre-treated | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 48 | 114 CD4+ cells/µL | Standard Deviation 200 |
| Pre-treated | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 60 | 144 CD4+ cells/µL | Standard Deviation 196 |
| Pre-treated | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 72 | 179 CD4+ cells/µL | Standard Deviation 193 |
| Pre-treated | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 96 | 192 CD4+ cells/µL | Standard Deviation 223 |
| Pre-treated | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 108 | 223 CD4+ cells/µL | Standard Deviation 227 |
| Pre-treated | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 120 | 217 CD4+ cells/µL | Standard Deviation 206 |
| Pre-treated | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 132 | 213 CD4+ cells/µL | Standard Deviation 167 |
| Pre-treated | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 144 | 251 CD4+ cells/µL | Standard Deviation 244 |
| Pre-treated | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 156 | 220 CD4+ cells/µL | Standard Deviation 183 |
| Pre-treated | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 180 | 174 CD4+ cells/µL | Standard Deviation 225 |
| Pre-treated | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 192 | 192 CD4+ cells/µL | Standard Deviation 186 |
| Pre-treated | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 204 | 131 CD4+ cells/µL | Standard Deviation 244 |
| Pre-treated | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 216 | 210 CD4+ cells/µL | Standard Deviation 243 |
| Pre-treated | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 228 | 208 CD4+ cells/µL | Standard Deviation 345 |
| Pre-treated | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 240 | 179 CD4+ cells/µL | Standard Deviation 185 |
| Pre-treated | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 4 | 68 CD4+ cells/µL | Standard Deviation 122 |
| Pre-treated | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 12 | 98 CD4+ cells/µL | Standard Deviation 204 |
| Pre-treated | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 84 | 181 CD4+ cells/µL | Standard Deviation 176 |
| Non-B | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 12 | 92 CD4+ cells/µL | Standard Deviation 117 |
| Non-B | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 180 | 422 CD4+ cells/µL | Standard Deviation 135 |
| Non-B | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 60 | 222 CD4+ cells/µL | Standard Deviation 206 |
| Non-B | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Baseline | 0 CD4+ cells/µL | Standard Deviation 0 |
| Non-B | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 192 | 474 CD4+ cells/µL | Standard Deviation 162 |
| Non-B | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 48 | 204 CD4+ cells/µL | Standard Deviation 173 |
| Non-B | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 240 | 542 CD4+ cells/µL | Standard Deviation 188 |
| Non-B | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 36 | 148 CD4+ cells/µL | Standard Deviation 134 |
| Non-B | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 4 | 131 CD4+ cells/µL | Standard Deviation 203 |
| Non-B | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 216 | 395 CD4+ cells/µL | Standard Deviation 230 |
| Non-B | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 24 | 128 CD4+ cells/µL | Standard Deviation 139 |
| Non-B | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 132 | 325 CD4+ cells/µL | Standard Deviation 218 |
| Non-B | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 120 | 275 CD4+ cells/µL | Standard Deviation 199 |
| Non-B | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 204 | 420 CD4+ cells/µL | Standard Deviation 172 |
| Non-B | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 144 | 320 CD4+ cells/µL | Standard Deviation 131 |
| Non-B | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 108 | 255 CD4+ cells/µL | Standard Deviation 195 |
| Non-B | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 228 | 399 CD4+ cells/µL | Standard Deviation 93 |
| Non-B | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 156 | 404 CD4+ cells/µL | Standard Deviation 162 |
| Non-B | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 96 | 239 CD4+ cells/µL | Standard Deviation 205 |
| Non-B | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 84 | 226 CD4+ cells/µL | Standard Deviation 161 |
| Non-B | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 168 | 426 CD4+ cells/µL | Standard Deviation 189 |
| Non-B | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | Week 72 | 259 CD4+ cells/µL | Standard Deviation 204 |
Secondary
Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml
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.
Time frame: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks
Population: All participants with HIV-1 RNA measurements at Baseline and any subsequent time point are presented, including those who discontinued due to virologic failure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Therapy-naive | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 240 | NA Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 192 | NA Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 84 | 2 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 24 | 3 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 180 | NA Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 96 | 0 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 168 | NA Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 108 | 0 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 132 | 3 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 156 | NA Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 144 | 0 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Baseline | 0 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 36 | 1 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 120 | 2 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 228 | NA Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 48 | 1 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 12 | 12 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 216 | NA Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 60 | 2 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 4 | 18 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 204 | NA Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 72 | 0 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 228 | 6 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Baseline | 3 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 4 | 12 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 12 | 15 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 24 | 6 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 36 | 9 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 48 | 0 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 60 | 6 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 72 | 6 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 84 | 5 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 108 | 0 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 132 | 0 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 144 | 10 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 156 | 10 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 168 | 10 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 180 | 0 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 192 | 10 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 204 | 0 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 216 | 0 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 240 | 6 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 96 | 7 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 120 | 9 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 84 | 3 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 12 | 17 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 180 | 8 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 72 | 8 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 4 | 19 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 192 | 0 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 60 | 9 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 240 | 0 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 204 | 0 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 48 | 13 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Baseline | 0 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 216 | 0 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 132 | 0 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 120 | 0 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 36 | 6 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 144 | 0 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 108 | 0 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 24 | 4 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 156 | 0 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 96 | 7 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 228 | 0 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | Week 168 | 0 Percentage of participants |
Secondary
Percentage of Patients With HIV-1 RNA >500 Copies/ml
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.
Time frame: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks
Population: All participants with HIV-1 RNA measurements at Baseline and any subsequent time point are presented, including those who discontinued due to virologic failure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Therapy-naive | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 180 | NA Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 84 | 2 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 24 | 6 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 168 | NA Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 96 | 4 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 60 | 7 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 156 | NA Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 108 | 5 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Baseline | 99 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 144 | 13 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 120 | 7 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 36 | 6 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 132 | 8 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 240 | NA Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 216 | NA Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 48 | 6 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 12 | 13 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 204 | NA Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 4 | 59 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 192 | NA Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 72 | 5 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 228 | NA Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 216 | 40 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Baseline | 89 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 4 | 46 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 12 | 32 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 24 | 17 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 36 | 23 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 48 | 21 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 60 | 18 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 72 | 15 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 84 | 16 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 96 | 26 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 108 | 26 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 120 | 26 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 132 | 36 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 144 | 26 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 156 | 43 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 168 | 38 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 180 | 42 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 192 | 40 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 204 | 53 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 228 | 50 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 240 | 56 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 84 | 3 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 240 | 0 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 168 | 9 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 72 | 6 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 228 | 0 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 180 | 0 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 60 | 6 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 4 | 63 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 192 | 0 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 48 | 3 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Baseline | 100 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 204 | 0 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 36 | 8 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 120 | 8 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 24 | 4 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 132 | 5 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 108 | 9 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 216 | 0 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 144 | 0 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 96 | 7 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 12 | 15 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA >500 Copies/ml | Week 156 | 0 Percentage of participants |
Secondary
Percentage of Patients With HIV-1 RNA <50 Copies/ml
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.
Time frame: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks
Population: All participants with HIV-1 RNA measurements at Baseline and any subsequent time point are presented, including those who discontinued due to virologic failure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Therapy-naive | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 72 | 89 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 240 | NA Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 180 | NA Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 84 | 87 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 216 | NA Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 144 | 88 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 96 | 90 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 24 | 69 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 132 | 87 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 108 | 81 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 4 | 7 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 120 | 85 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 204 | NA Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 36 | 75 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Baseline | 0 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 192 | NA Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 48 | 83 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 228 | NA Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 168 | NA Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 60 | 78 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 12 | 44 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 156 | NA Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 144 | 65 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Baseline | 3 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 4 | 26 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 12 | 38 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 24 | 58 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 36 | 60 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 48 | 67 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 60 | 65 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 72 | 62 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 84 | 66 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 96 | 58 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 108 | 66 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 120 | 63 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 132 | 52 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 156 | 48 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 168 | 52 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 180 | 53 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 192 | 45 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 204 | 41 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 228 | 44 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 240 | 38 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 216 | 50 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 168 | 91 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 156 | 100 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 48 | 80 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 228 | 75 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Baseline | 0 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 180 | 83 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 36 | 76 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 216 | 100 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 192 | 100 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 24 | 74 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 240 | 100 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 204 | 100 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 108 | 87 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 12 | 42 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 120 | 88 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 96 | 77 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 4 | 5 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 132 | 95 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 84 | 88 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 72 | 83 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 144 | 100 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA <50 Copies/ml | Week 60 | 79 Percentage of participants |
Secondary
Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml
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.
Time frame: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks
Population: All participants with HIV-1 RNA measurements at Baseline and any subsequent time point are presented, including those who discontinued due to virologic failure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Therapy-naive | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 168 | NA Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 84 | 9 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 228 | NA Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 156 | NA Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 96 | 6 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 24 | 22 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 144 | 0 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 108 | 14 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Baseline | 1 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 132 | 3 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 120 | 5 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 216 | NA Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 36 | 18 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 240 | NA Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 204 | NA Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 48 | 10 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 12 | 32 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 192 | NA Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 60 | 13 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 4 | 17 Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 180 | NA Percentage of participants |
| Therapy-naive | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 72 | 5 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 72 | 17 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Baseline | 5 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 4 | 15 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 12 | 15 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 24 | 20 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 36 | 9 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 48 | 12 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 60 | 10 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 84 | 13 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 96 | 9 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 108 | 8 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 120 | 3 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 132 | 13 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 144 | 0 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 156 | 0 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 168 | 0 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 180 | 5 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 192 | 5 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 204 | 6 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 216 | 10 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 228 | 0 Percentage of participants |
| Pre-treated | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 240 | 0 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 72 | 3 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 12 | 25 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 168 | 0 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 60 | 6 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 240 | 0 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 180 | 8 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 48 | 5 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 228 | 25 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 192 | 0 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 36 | 10 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 4 | 14 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 204 | 0 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 120 | 4 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 108 | 4 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 24 | 18 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 132 | 0 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 96 | 10 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Baseline | 0 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 144 | 0 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 84 | 6 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 216 | 0 Percentage of participants |
| Non-B | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | Week 156 | 0 Percentage of participants |