Phase 3
Completed N=89
Dolutegravir Antiretroviral Strategy to Promote Improvement and Reduce Drug Exposure
Source: ClinicalTrials.gov NCT02263326 ↗Enrolled (actual)
89
Serious AEs
3.4%
Results posted
Nov 2018
Primary outcomePrimary: Proportion of Participants With Treatment Failure — 0.0682; 0.0667 proportion of participants
◆ Published Evidence
Established
85citations · ~11 / year
Dolutegravir Plus Lamivudine Maintains Human Immunodeficiency Virus-1 Suppression Through Week 48 in a Pilot Randomized Trial.
Summary
HIV-1 infected subjects with CD4 nadir > 200 cells/mm3, no history of virologic failure and plasma HIV RNA 50 copies/mL before or at Week 24
Linked Publications
-
Dolutegravir Plus Lamivudine Maintains Human Immunodeficiency Virus-1 Suppression Through Week 48 in a Pilot Randomized Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants With Treatment Failure |
0.0682; 0.0667 | — |
| SECONDARY Proportion of Participants With Virologic Success |
0.9091; 0.8889 | — |
| SECONDARY Change in CD4 Count From Baseline to Week 48 |
39; 28 | 0.866 |
| SECONDARY Change in Total Cholesterol From Baseline to Week 48 |
0; -1 | 0.613 |
| SECONDARY Change in LDL Cholesterol From Baseline to Week 48 |
2; -3 | 0.420 |
| SECONDARY Change in Creatinine Clearance From Baseline to Week 48 |
-4; 0 | 0.074 |
| SECONDARY Drug Resistance Associated Mutations |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- HIV-1 Infection
- HIV-1 RNA 50 copies/mL after 12 months of initiating ART. An isolated (non-consecutive) HIV RNA > 50 copies/mL (but less than 400 copies/mL) is permitted after 12 months of initiating ART but not in the 48-week window prior to study entry.
- Screening plasma HIV RNA 200 cells/mm
- Pretreatment genotype documenting no mutations in the protease or reverse transcriptase genes
- No known resistance to integrase inhibitors
- Laboratory values obtained within 45 days prior to study entry:
ANC >750 Hemoglobin >10 g/dL Platelets >50,000 Calculated creatinine clearance (CrCl) >50 mL/min
- Negative serum or urine pregnancy test
- Men and women age greater or equal to 18 years.
- Ability to continue current regimen (i.e, have uninterrupted access)
- No evidence of chronic hepatitis B
Exclusion Criteria
- Serious illness or AIDS-related complication within 21 days of screening requiring systemic treatment and/or hospitalization
- Treatment within 30 days prior to study entry with immune modulators
- Vaccination within 7 days
- Active HCV treatment or anticipated need for treatment within study period. (HCV infection alone is not exclusionary)
- Unstable liver disease or severe hepatic impairment
- Known allergy or hypersensitivity to DTG or lamivudine.
- Active drug or alcohol use or dependence that could interfere with adherence to study requirements
- ALT (alanine aminotransferase) >5 x ULN (upper limit of normal) OR ALT >3 x ULN and total bilirubin >1.5 x ULN (with 35% direct bilirubin)
Data sourced from ClinicalTrials.gov (NCT02263326) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.