NCT03198884

A Retrospective Study to Evaluate the Safety and Efficacy of a Nucleoside-Sparing Regimen of Darunavir, Ritonavir, and Dolutegravir

Completed Results posted Last updated 1 September 2020

What this trial tests

trial testing Darunavir 800 MG, Norvir 100 MG, Dolutegravir 50 MG in HIV-1-infection in 20 participants. Completed in 1 May 2018.

Timeline

1 January 2017

Primary endpoint
18 April 2018

1 May 2018

Quick facts

Lead sponsor	Southern Illinois Healthcare Foundation
Status	Completed
Study type	OBSERVATIONAL
Enrollment	20
Start date	1 January 2017
Primary completion	18 April 2018
Estimated completion	1 May 2018

Drugs / interventions tested

• Darunavir 800 MG, Norvir 100 MG, Dolutegravir 50 MG — full drug profile →

Conditions studied

• HIV-1-infection — all drugs for HIV-1-infection →

Sponsor

Southern Illinois Healthcare Foundation

Who can join

18 and older, 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.

Number of Participants With RNA <50 Copies/mL at 48 Weeks Primary · 48 weeks

Our first primary endpoint evaluated the percent of study subjects with an RNA \<50 copies/mL at 48 weeks after initiation of the once daily two-drug regimen.

Group	Value	95% CI
Retrospective Chart Review	19

The Change in Serum Creatinine From Baseline to 48 Weeks. Primary · 48 weeks

A second primary endpoint was evaluating the change in serum creatinine from baseline to 48 weeks for all subjects.

Group	Value	95% CI
Retrospective Chart Review	73.4	69.1 – 77.7

Change in Mean CD4+ Cell Count From Baseline. Secondary · 48 weeks

A secondary endpoint included changes from baseline in CD4+ cell counts.

Group	Value	95% CI
Week 24	454	± 301
Week 36	428	± 254
Week 48	456	± 291

Incidence of Adverse Events. Secondary · 48 weeks

10 study subjects reported an adverse event.

Insomnia

Group	Value	95% CI
Retrospective Chart Review	6

Diarrhea

Group	Value	95% CI
Retrospective Chart Review	4

Headache

Group	Value	95% CI
Retrospective Chart Review	3

Number of Grade 1 Adverse Events Reported Secondary · 48 weeks

10 study subjects reported adverse events. All adverse events reported (insomnia, diarrhea, headache) were of Grade 1 severity. There were no adverse events that led to discontinuation of the study regimen.

Insomnia

Group	Value	95% CI
Adverse Events	6

Diarrhea

Group	Value	95% CI
Adverse Events	4

Headache

Group	Value	95% CI
Adverse Events	3

Number of Participants With RNA <50 Copies/mL at 24, 36, and 48 Weeks Secondary · 48 weeks

This secondary outcome measure analyzed the percentage of subjects with \< 50 copies/mL RNA at time points 24, 36 and 48 weeks. The percent of subjects with an RNA \< 50 copies/mL at each time point was analyzed using McNemar's test following the guidelines of the Snapshot algorithm. Missing RNA data was considered a treatment failure.

Group	Value	95% CI
Analysis of HIV RNA at Week 24	19
Analysis of HIV RNA at Week 36	14
Analysis of HIV RNA at Week 48	19

Analysis of Creatinine Clearance at Time Points 24, 36 and 48 Weeks. Secondary · 48 weeks

Group	Value	95% CI
Analysis of Serum Creatinine at Week 24	75.8	56.4 – 95.4
Analysis of Serum Creatinine at Week 36	69.1	47.4 – 90.7
Analyis of Serum Creatinine at Week 48	77.7	57.0 – 98.5

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data was collected for a total of 3 months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Retrospective Chart Review

Serious: 0/20 (0%)

Deaths: 0/20

Other adverse events (3 terms — click to expand)

Reaction	System	Retrospective Chart Review
insomnia	Nervous system disorders	—
Diarrhea	Gastrointestinal disorders	—
Headache	Nervous system disorders	—

Data from ClinicalTrials.gov NCT03198884 adverse events section.

Sponsor's own description

A Retrospective Study to Evaluate the Safety and Efficacy of a Nucleoside-Sparing Regimen of Darunavir, Ritonavir, and Dolutegravir

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. 552. Evaluation of Relationships Between UGT1A1 Genotypes and Cabotegravir Long-Acting Injection Pharmacokinetics Among HIV-Infected Subjects in the LATTE-2 Study
   Xue Z, King K, Ford S, Lou Y, et al · · 2018
2. 551. MK-8591 Does Not Alter the Pharmacokinetics of the Oral Contraceptives Ethinyl Estradiol and Levonorgestrel
   Ankrom W, Jonathan D, Rudd D, Zhang S, et al · · 2018
3. 553. A Retrospective Study to Evaluate the Safety and Efficacy of a Nucleoside-Sparing Regimen of Darunavir, Ritonavir, and Dolutegravir
   Verna J, Austin S. · · 2018
4. 550. Adherence and Persistency With Modern Single vs. Multi-Tablet Antiretroviral (ARV) Regimens in First Treatment of HIV in Clinical Practice
   Mills A, Priest J, Musallam A, Althoff K, et al · · 2018