Phase 3 N=89 Randomized Treatment

Dolutegravir Antiretroviral Strategy to Promote Improvement and Reduce Drug Exposure

HIV Infection

Bottom Line

View on ClinicalTrials.gov: NCT02263326 ↗

Enrolled (actual)

Serious AEs

3.4%

Results posted

Nov 2018

Primary outcome: Primary: Proportion of Participants With Treatment Failure — 0.0682; 0.0667 proportion of participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: dolutegravir (Drug); lamivudine (Drug); Continue current antiretroviral regimen (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Babafemi Taiwo
Primary completion: Jul 2017

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	—

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

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02263326). 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.