Percentage of Participants on Dual Therapy (LPV/r + 3TC) With Undetectable HIV-1 RNA Level at Week 48
Primary
· Week 48
| Group | Value | 95% CI |
|---|---|---|
| HIV-1 Infected Participants | 100 | 98.18 – 100.0 |
Last reviewed · How we verify
NCT02581202: SIMPLE
The Effectiveness of Dual Therapy (Lopinavir/Ritonavir + LamivudinE) in Treatment-Experienced HIV Infected Patients in the Russian Federation
Completed
Results posted
Last updated 6 June 2019
What this trial tests
trial testing lopinavir/ritonavir in HIV-1 Infection in 216 participants. Completed in 27 May 2017.
Timeline
21 December 2015
Primary endpoint
27 May 2017
27 May 2017
27 May 2017
Quick facts
| Lead sponsor | AbbVie |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 216 |
| Start date | 21 December 2015 |
| Primary completion | 27 May 2017 |
| Estimated completion | 27 May 2017 |
Drugs / interventions tested
- lopinavir/ritonavir
- lamivudine (LAMIVUDINE) — full drug profile →
Conditions studied
- HIV-1 Infection — all drugs for HIV-1 Infection →
Sponsor
AbbVie — full company profile →
Who can join
Adults 18 to 80, any sex, with HIV-1 Infection. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants on Dual Therapy (LPV/r + 3TC) With Undetectable HIV-1 RNA Level at Week 24
Secondary
· Week 24
| Group | Value | 95% CI |
|---|---|---|
| HIV-1 Infected Participants | 99.5 | 97.29 – 99.99 |
Absolute Values and Change From Baseline (BL) in HIV-1- RNA Viral Load at Week 24 (Untransformed Data)
Secondary
· Baseline, Week 24
Absolute values
| Group | Value | 95% CI |
|---|---|---|
| HIV-1 Infected Participants | 25.22 | ± 3.158 |
Change from BL
| Group | Value | 95% CI |
|---|---|---|
| HIV-1 Infected Participants | 0.22 | ± 3.158 |
Absolute Values and Change From Baseline (BL) in HIV-1- RNA Viral Load at Week 24 (Base-10 Logarithm Transformed Data)
Secondary
· Baseline, Week 24
Absolute values
| Group | Value | 95% CI |
|---|---|---|
| HIV-1 Infected Participants | 3.22 | ± 0.072 |
Change from BL
| Group | Value | 95% CI |
|---|---|---|
| HIV-1 Infected Participants | 0.01 | ± 0.072 |
Absolute Values and Change From Baseline in HIV-1- RNA Viral Load at Week 48 (Untransformed Data)
Secondary
· Baseline, Week 48
Statistics for absolute HIV-1 RNA viral load, where all participants with undetectable HIV-1-RNA viral load data were included into calculations with half of the lower indication limit (50/2 copies/mL, or 25.00 copies/mL).
Absolute values
| Group | Value | 95% CI |
|---|---|---|
| HIV-1 Infected Participants | 25.00 | ± 0.000 |
Change from BL
| Group | Value | 95% CI |
|---|---|---|
| HIV-1 Infected Participants | 0.00 | ± 0.000 |
Absolute Values and Change From Baseline in HIV-1- RNA Viral Load at Week 48 (Base-10 Logarithm Transformed Data)
Secondary
· Baseline, Week 48
Absolute values
| Group | Value | 95% CI |
|---|---|---|
| HIV-1 Infected Participants | 3.22 | ± 0.000 |
Change from BL
| Group | Value | 95% CI |
|---|---|---|
| HIV-1 Infected Participants | 0.000 | ± 0.000 |
Absolute Values and Change From Baseline in CD4+ T-cell Counts (%) at Week 24
Secondary
· Baseline, Week 24
Absolute values
| Group | Value | 95% CI |
|---|---|---|
| HIV-1 Infected Participants | 32.50 | ± 7.554 |
Change from BL
| Group | Value | 95% CI |
|---|---|---|
| HIV-1 Infected Participants | 0.96 | ± 4.879 |
Absolute Values and Change From Baseline in CD4+ T-cell Counts (%) at Week 48
Secondary
· Baseline, Week 48
Absolute values
| Group | Value | 95% CI |
|---|---|---|
| HIV-1 Infected Participants | 33.11 | ± 7.860 |
Change from BL
| Group | Value | 95% CI |
|---|---|---|
| HIV-1 Infected Participants | 1.43 | ± 6.314 |
Absolute Values and Change From Baseline in CD4+ T-cell Counts (Cells/mm^3) at Week 24
Secondary
· Baseline, Week 24
Absolute values
| Group | Value | 95% CI |
|---|---|---|
| HIV-1 Infected Participants | 703.43 | ± 223.790 |
Change from BL
| Group | Value | 95% CI |
|---|---|---|
| HIV-1 Infected Participants | 64.70 | ± 165.060 |
Absolute Values and Change From Baseline in CD4+ T-cell Counts (Cells/mm^3) at Week 48
Secondary
· Baseline, Week 48
Absolute values
| Group | Value | 95% CI |
|---|---|---|
| HIV-1 Infected Participants | 752.44 | ± 234.366 |
Change from BL
| Group | Value | 95% CI |
|---|---|---|
| HIV-1 Infected Participants | 111.75 | ± 184.477 |
Number of Participants Who Developed Resistance to Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Non-nucleoside Reverse Transcriptase Inhibitors (NNRTIs), and Protease Inhibitors (PIs)
Secondary
· Week 48
NRTI
| Group | Value | 95% CI |
|---|---|---|
| HIV-1 Infected Participants | 1 |
NNRTI
| Group | Value | 95% CI |
|---|---|---|
| HIV-1 Infected Participants | 1 |
PI
| Group | Value | 95% CI |
|---|---|---|
| HIV-1 Infected Participants | 0 |
Absolute Values and Change From Baseline in Anthropometric Measurements At Week 24
Secondary
· Baseline, Week 24
Absolute values: arm circumference
| Group | Value | 95% CI |
|---|---|---|
| HIV-1 Infected Participants | 29.82 | ± 4.617 |
Change from BL: arm circumference
| Group | Value | 95% CI |
|---|---|---|
| HIV-1 Infected Participants | -0.38 | ± 2.953 |
Absolute values: hip circumference
| Group | Value | 95% CI |
|---|---|---|
| HIV-1 Infected Participants | 54.62 | ± 8.112 |
Change from BL: hip circumference
| Group | Value | 95% CI |
|---|---|---|
| HIV-1 Infected Participants | 0.57 | ± 5.575 |
Absolute values: waist circumference
| Group | Value | 95% CI |
|---|---|---|
| HIV-1 Infected Participants | 83.29 | ± 12.282 |
Change from BL: waist circumference
| Group | Value | 95% CI |
|---|---|---|
| HIV-1 Infected Participants | 0.31 | ± 5.998 |
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to Week 48. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
HIV-1 Infected Participants
Serious: 0/216 (0%)
Deaths: 0/216
Other adverse events (6 terms — click to expand)
| Reaction | System | HIV-1 Infected Participants |
|---|---|---|
| Diarrhoea | Gastrointestinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Drug ineffective | General disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Dyspepsia | Gastrointestinal disorders | — |
| Transaminases increased | Investigations | — |
Data from ClinicalTrials.gov NCT02581202 adverse events section.
Sponsor's own description
This study seeks to assess the virologic effectiveness of dual therapy (lopinavir/ ritonavir (LPV/r) + lamivudine (3TC)) in treatment-experienced human immunodeficiency virus 1 (HIV-1) infected participants with an undetectable plasma HIV-1 (ribonucleic acid) RNA level (for at least 6 months) at the 48 week time point of treatment in the routine clinical settings of the Russian Federation.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02581202
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT02581202 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by AbbVie
- Last refreshed: 6 June 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02581202.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing