Trial Outcomes & Findings for Safety & Efficacy of Dual Therapy With Raltegravir/Lamivudine (NCT NCT02284035)
NCT ID: NCT02284035
Last Updated: 2025-07-20
Results Overview
Proportion of patients free of therapeutic failure at week 24. Therapeutic failure includes virological failure, change in treatment for any reason, consent withdrawal, loss to follow-up or death
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
75 participants
Primary outcome timeframe
24 weeks
Results posted on
2025-07-20
Participant Flow
A total of 75 participants were enrolled and randomized. One participant assigned to the Raltegravir/Lamivudine arm withdrew consent before starting treatment and was excluded from the analysis. As a result, 74 participants initiated treatment.
Participant milestones
| Measure |
Group 1 Raltegravir / 3TC (MK0518B)
Raltegravir / 3TC (MK0518B )
Raltegravir/3TC: MK0518B (Raltegravir/3TC) (300mg/150mg) twice daily, administered orally in the 300/150 mg film-coated tablets according to instructions in the prescribing information.
|
Group 2 Standard Combination Therapy
NNRTI-Based Regimen:
• EFV/TDF/FTC
PI-Based Regimens:
ATV/r + TDF/FTC or DRV/r + TDF/FTC
INSTI-Based Regimens:
DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC
NNRTI-Based Regimens:
EFV plus ABC/3TC or RPV/TDF/FTC
PI-Based Regimen:
ATV/r plus ABC/3TC
PI-Based Regimens:
DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC
INSTI-Based Regimen:
RAL plus ABC/3TC
And other ART regimens
EFV/TDF/FTC: standard combination therapy
ATV/r + TDF/FTC or DRV/r + TDF/FTC
DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC
EFV plus ABC/3TC or RPV/TDF/FTC
ATV/r plus ABC/3TC
DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC
RAL plus ABC/3TC
Other ART regimens
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
25
|
|
Overall Study
COMPLETED
|
47
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety & Efficacy of Dual Therapy With Raltegravir/Lamivudine
Baseline characteristics by cohort
| Measure |
Group 1 Raltegravir / 3TC (MK0518B)
n=49 Participants
Raltegravir / 3TC (MK0518B )
Raltegravir/3TC: MK0518B (Raltegravir/3TC) (300mg/150mg) twice daily, administered orally in the 300/150 mg film-coated tablets according to instructions in the prescribing information.
|
Group 2 Standard Combination Therapy
n=25 Participants
NNRTI-Based Regimen:
• EFV/TDF/FTC
PI-Based Regimens:
ATV/r + TDF/FTC or DRV/r + TDF/FTC
INSTI-Based Regimens:
DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC
NNRTI-Based Regimens:
EFV plus ABC/3TC or RPV/TDF/FTC
PI-Based Regimen:
ATV/r plus ABC/3TC
PI-Based Regimens:
DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC
INSTI-Based Regimen:
RAL plus ABC/3TC
And other ART regimens
EFV/TDF/FTC: standard combination therapy
ATV/r + TDF/FTC or DRV/r + TDF/FTC
DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC
EFV plus ABC/3TC or RPV/TDF/FTC
ATV/r plus ABC/3TC
DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC
RAL plus ABC/3TC
Other ART regimens
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50 years
STANDARD_DEVIATION 12 • n=5 Participants
|
50 years
STANDARD_DEVIATION 13 • n=7 Participants
|
50 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
49 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: A total of 75 subjects were randomized. However, in the RAL/3TC group (n=50), one subject was excluded due to consent withdrawal prior to the initiation of medication and therefore did not complete the Baseline (randomization) visit.
Proportion of patients free of therapeutic failure at week 24. Therapeutic failure includes virological failure, change in treatment for any reason, consent withdrawal, loss to follow-up or death
Outcome measures
| Measure |
Group 1 Raltegravir / 3TC (MK0518B
n=49 Participants
Raltegravir / 3TC (MK0518B ) (50 patients)
Raltegravir/3TC: MK0518B (Raltegravir/3TC) (300mg/150mg) twice daily, administered orally in the 300/150 mg film-coated tablets according to instructions in the prescribing information.
|
Group 2 Standard Combination Therapy
n=25 Participants
NNRTI-Based Regimen:
• EFV/TDF/FTC
PI-Based Regimens:
ATV/r + TDF/FTC or DRV/r + TDF/FTC
INSTI-Based Regimens:
DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC
NNRTI-Based Regimens:
EFV plus ABC/3TC or RPV/TDF/FTC
PI-Based Regimen:
ATV/r plus ABC/3TC
PI-Based Regimens:
DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC
INSTI-Based Regimen:
RAL plus ABC/3TC
And other ART regimens
EFV/TDF/FTC: standard combination therapy
ATV/r + TDF/FTC or DRV/r + TDF/FTC
DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC
EFV plus ABC/3TC or RPV/TDF/FTC
ATV/r plus ABC/3TC
DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC
RAL plus ABC/3TC
Other ART regimens
|
|---|---|---|
|
Proportion of Patients Free of Therapeutic Failure
No events
|
47 Participants
|
20 Participants
|
|
Proportion of Patients Free of Therapeutic Failure
Lost to follow up
|
0 Participants
|
2 Participants
|
|
Proportion of Patients Free of Therapeutic Failure
Pregnancy
|
1 Participants
|
0 Participants
|
|
Proportion of Patients Free of Therapeutic Failure
Stops treatment
|
0 Participants
|
2 Participants
|
|
Proportion of Patients Free of Therapeutic Failure
Virological faiulure
|
0 Participants
|
1 Participants
|
|
Proportion of Patients Free of Therapeutic Failure
Stops study medical decision
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 24 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 weeksComposite measure
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 weeksPopulation: Some patients were not performed a DEXA during the study
Composite measure
Outcome measures
| Measure |
Group 1 Raltegravir / 3TC (MK0518B
n=46 Participants
Raltegravir / 3TC (MK0518B ) (50 patients)
Raltegravir/3TC: MK0518B (Raltegravir/3TC) (300mg/150mg) twice daily, administered orally in the 300/150 mg film-coated tablets according to instructions in the prescribing information.
|
Group 2 Standard Combination Therapy
n=25 Participants
NNRTI-Based Regimen:
• EFV/TDF/FTC
PI-Based Regimens:
ATV/r + TDF/FTC or DRV/r + TDF/FTC
INSTI-Based Regimens:
DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC
NNRTI-Based Regimens:
EFV plus ABC/3TC or RPV/TDF/FTC
PI-Based Regimen:
ATV/r plus ABC/3TC
PI-Based Regimens:
DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC
INSTI-Based Regimen:
RAL plus ABC/3TC
And other ART regimens
EFV/TDF/FTC: standard combination therapy
ATV/r + TDF/FTC or DRV/r + TDF/FTC
DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC
EFV plus ABC/3TC or RPV/TDF/FTC
ATV/r plus ABC/3TC
DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC
RAL plus ABC/3TC
Other ART regimens
|
|---|---|---|
|
Changes in Body Fat Composition
Baseline extremities fat percentage
|
54.13 percentage of fat weight
Standard Deviation 19.44
|
49.43 percentage of fat weight
Standard Deviation 21.26
|
|
Changes in Body Fat Composition
Baseline total fat percentage
|
28.50 percentage of fat weight
Standard Deviation 7.62
|
27.54 percentage of fat weight
Standard Deviation 8.75
|
|
Changes in Body Fat Composition
Week 24 extremities fat percentage
|
54.09 percentage of fat weight
Standard Deviation 17.68
|
50.21 percentage of fat weight
Standard Deviation 23.77
|
|
Changes in Body Fat Composition
Week 24 total fat percentage
|
28.84 percentage of fat weight
Standard Deviation 7.23
|
28.78 percentage of fat weight
Standard Deviation 9.55
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Some patients vitamine D determination was not available
Outcome measures
| Measure |
Group 1 Raltegravir / 3TC (MK0518B
n=45 Participants
Raltegravir / 3TC (MK0518B ) (50 patients)
Raltegravir/3TC: MK0518B (Raltegravir/3TC) (300mg/150mg) twice daily, administered orally in the 300/150 mg film-coated tablets according to instructions in the prescribing information.
|
Group 2 Standard Combination Therapy
n=24 Participants
NNRTI-Based Regimen:
• EFV/TDF/FTC
PI-Based Regimens:
ATV/r + TDF/FTC or DRV/r + TDF/FTC
INSTI-Based Regimens:
DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC
NNRTI-Based Regimens:
EFV plus ABC/3TC or RPV/TDF/FTC
PI-Based Regimen:
ATV/r plus ABC/3TC
PI-Based Regimens:
DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC
INSTI-Based Regimen:
RAL plus ABC/3TC
And other ART regimens
EFV/TDF/FTC: standard combination therapy
ATV/r + TDF/FTC or DRV/r + TDF/FTC
DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC
EFV plus ABC/3TC or RPV/TDF/FTC
ATV/r plus ABC/3TC
DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC
RAL plus ABC/3TC
Other ART regimens
|
|---|---|---|
|
Changes in Plasma 25-OH Vitamin D Levels
Baseline
|
17.4 ng/mL
Standard Deviation 9.0
|
16.7 ng/mL
Standard Deviation 9.6
|
|
Changes in Plasma 25-OH Vitamin D Levels
week 24
|
29.5 ng/mL
Standard Deviation 15.1
|
26.5 ng/mL
Standard Deviation 17.2
|
SECONDARY outcome
Timeframe: 24 weeksComposite measure
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 weeksPopulation: Some patients did not complete the questionnaire
The Pittsburgh Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in adults. It differentiates "poor" from "good" sleep quality by measuring seven áreas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the last month. The posible range of the scale is from 0 to 21 points. The greater the score the poorest is the sleep quality.
Outcome measures
| Measure |
Group 1 Raltegravir / 3TC (MK0518B
n=46 Participants
Raltegravir / 3TC (MK0518B ) (50 patients)
Raltegravir/3TC: MK0518B (Raltegravir/3TC) (300mg/150mg) twice daily, administered orally in the 300/150 mg film-coated tablets according to instructions in the prescribing information.
|
Group 2 Standard Combination Therapy
n=22 Participants
NNRTI-Based Regimen:
• EFV/TDF/FTC
PI-Based Regimens:
ATV/r + TDF/FTC or DRV/r + TDF/FTC
INSTI-Based Regimens:
DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC
NNRTI-Based Regimens:
EFV plus ABC/3TC or RPV/TDF/FTC
PI-Based Regimen:
ATV/r plus ABC/3TC
PI-Based Regimens:
DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC
INSTI-Based Regimen:
RAL plus ABC/3TC
And other ART regimens
EFV/TDF/FTC: standard combination therapy
ATV/r + TDF/FTC or DRV/r + TDF/FTC
DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC
EFV plus ABC/3TC or RPV/TDF/FTC
ATV/r plus ABC/3TC
DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC
RAL plus ABC/3TC
Other ART regimens
|
|---|---|---|
|
Changes in Sleep Quality (Pittsburgh Sleep Quality Index)
Baseline score
|
5 score on a scale
Standard Deviation 3.5
|
4.7 score on a scale
Standard Deviation 3.1
|
|
Changes in Sleep Quality (Pittsburgh Sleep Quality Index)
Week 24 score
|
4.8 score on a scale
Standard Deviation 3.1
|
5.1 score on a scale
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Some patients did not complete the questionnaire
Patients were asked to complete the Morisky-Green questionnaire: Some people forget to take their medication as prescribed. How often does it happen to you? (Always/often/sometimes/rarely/never) Some people forget some taking of the medication or change the prescribed schedule / take to adapt it to their own needs. How often do you do it? (Always/often/sometimes/rarely/never) Some people stop taking their medications as prescribed when they feel better. How often do you do it? (Always/often/sometimes/rarely/never) Some people stop taking their medications as prescribed when they feel worse. How often do you do it? (Always/often/sometimes/rarely/never) Only if patients answered never to each four questions, they were considered adherent; if not, non adherent.
Outcome measures
| Measure |
Group 1 Raltegravir / 3TC (MK0518B
n=49 Participants
Raltegravir / 3TC (MK0518B ) (50 patients)
Raltegravir/3TC: MK0518B (Raltegravir/3TC) (300mg/150mg) twice daily, administered orally in the 300/150 mg film-coated tablets according to instructions in the prescribing information.
|
Group 2 Standard Combination Therapy
n=25 Participants
NNRTI-Based Regimen:
• EFV/TDF/FTC
PI-Based Regimens:
ATV/r + TDF/FTC or DRV/r + TDF/FTC
INSTI-Based Regimens:
DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC
NNRTI-Based Regimens:
EFV plus ABC/3TC or RPV/TDF/FTC
PI-Based Regimen:
ATV/r plus ABC/3TC
PI-Based Regimens:
DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC
INSTI-Based Regimen:
RAL plus ABC/3TC
And other ART regimens
EFV/TDF/FTC: standard combination therapy
ATV/r + TDF/FTC or DRV/r + TDF/FTC
DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC
EFV plus ABC/3TC or RPV/TDF/FTC
ATV/r plus ABC/3TC
DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC
RAL plus ABC/3TC
Other ART regimens
|
|---|---|---|
|
Changes in Adherence in Both Treatment Arms (Morisky-Green Test)
Baseline · Adherent
|
19 Participants
|
11 Participants
|
|
Changes in Adherence in Both Treatment Arms (Morisky-Green Test)
Baseline · Non adherent
|
29 Participants
|
13 Participants
|
|
Changes in Adherence in Both Treatment Arms (Morisky-Green Test)
Baseline · Not evaluated/ Lost follow Up
|
1 Participants
|
1 Participants
|
|
Changes in Adherence in Both Treatment Arms (Morisky-Green Test)
Week 24 · Adherent
|
19 Participants
|
14 Participants
|
|
Changes in Adherence in Both Treatment Arms (Morisky-Green Test)
Week 24 · Non adherent
|
27 Participants
|
5 Participants
|
|
Changes in Adherence in Both Treatment Arms (Morisky-Green Test)
Week 24 · Not evaluated/ Lost follow Up
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Some patients have not performed all the protocol determinations
Outcome measures
| Measure |
Group 1 Raltegravir / 3TC (MK0518B
n=49 Participants
Raltegravir / 3TC (MK0518B ) (50 patients)
Raltegravir/3TC: MK0518B (Raltegravir/3TC) (300mg/150mg) twice daily, administered orally in the 300/150 mg film-coated tablets according to instructions in the prescribing information.
|
Group 2 Standard Combination Therapy
n=25 Participants
NNRTI-Based Regimen:
• EFV/TDF/FTC
PI-Based Regimens:
ATV/r + TDF/FTC or DRV/r + TDF/FTC
INSTI-Based Regimens:
DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC
NNRTI-Based Regimens:
EFV plus ABC/3TC or RPV/TDF/FTC
PI-Based Regimen:
ATV/r plus ABC/3TC
PI-Based Regimens:
DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC
INSTI-Based Regimen:
RAL plus ABC/3TC
And other ART regimens
EFV/TDF/FTC: standard combination therapy
ATV/r + TDF/FTC or DRV/r + TDF/FTC
DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC
EFV plus ABC/3TC or RPV/TDF/FTC
ATV/r plus ABC/3TC
DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC
RAL plus ABC/3TC
Other ART regimens
|
|---|---|---|
|
Changes in Total Cholesterol
Baseline
|
189 mg/dl
Standard Deviation 46
|
187 mg/dl
Standard Deviation 44
|
|
Changes in Total Cholesterol
Week 24
|
190 mg/dl
Standard Deviation 45
|
186 mg/dl
Standard Deviation 37
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Some patients did not performed all the determinations
Outcome measures
| Measure |
Group 1 Raltegravir / 3TC (MK0518B
n=49 Participants
Raltegravir / 3TC (MK0518B ) (50 patients)
Raltegravir/3TC: MK0518B (Raltegravir/3TC) (300mg/150mg) twice daily, administered orally in the 300/150 mg film-coated tablets according to instructions in the prescribing information.
|
Group 2 Standard Combination Therapy
n=25 Participants
NNRTI-Based Regimen:
• EFV/TDF/FTC
PI-Based Regimens:
ATV/r + TDF/FTC or DRV/r + TDF/FTC
INSTI-Based Regimens:
DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC
NNRTI-Based Regimens:
EFV plus ABC/3TC or RPV/TDF/FTC
PI-Based Regimen:
ATV/r plus ABC/3TC
PI-Based Regimens:
DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC
INSTI-Based Regimen:
RAL plus ABC/3TC
And other ART regimens
EFV/TDF/FTC: standard combination therapy
ATV/r + TDF/FTC or DRV/r + TDF/FTC
DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC
EFV plus ABC/3TC or RPV/TDF/FTC
ATV/r plus ABC/3TC
DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC
RAL plus ABC/3TC
Other ART regimens
|
|---|---|---|
|
Changes in HDL Cholesterol
Baseline
|
48 mg/dl
Standard Deviation 15
|
46 mg/dl
Standard Deviation 13
|
|
Changes in HDL Cholesterol
Week 24
|
49 mg/dl
Standard Deviation 14
|
45 mg/dl
Standard Deviation 15
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Some patients did not perform all the determinations
Outcome measures
| Measure |
Group 1 Raltegravir / 3TC (MK0518B
n=45 Participants
Raltegravir / 3TC (MK0518B ) (50 patients)
Raltegravir/3TC: MK0518B (Raltegravir/3TC) (300mg/150mg) twice daily, administered orally in the 300/150 mg film-coated tablets according to instructions in the prescribing information.
|
Group 2 Standard Combination Therapy
n=22 Participants
NNRTI-Based Regimen:
• EFV/TDF/FTC
PI-Based Regimens:
ATV/r + TDF/FTC or DRV/r + TDF/FTC
INSTI-Based Regimens:
DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC
NNRTI-Based Regimens:
EFV plus ABC/3TC or RPV/TDF/FTC
PI-Based Regimen:
ATV/r plus ABC/3TC
PI-Based Regimens:
DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC
INSTI-Based Regimen:
RAL plus ABC/3TC
And other ART regimens
EFV/TDF/FTC: standard combination therapy
ATV/r + TDF/FTC or DRV/r + TDF/FTC
DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC
EFV plus ABC/3TC or RPV/TDF/FTC
ATV/r plus ABC/3TC
DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC
RAL plus ABC/3TC
Other ART regimens
|
|---|---|---|
|
Changes in LDL Cholesterol
Baseline
|
120 mg/dl
Standard Deviation 39
|
115 mg/dl
Standard Deviation 29
|
|
Changes in LDL Cholesterol
Week 24
|
119 mg/dl
Standard Deviation 40
|
118 mg/dl
Standard Deviation 33
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: All patients did not perform all the determinations
Outcome measures
| Measure |
Group 1 Raltegravir / 3TC (MK0518B
n=49 Participants
Raltegravir / 3TC (MK0518B ) (50 patients)
Raltegravir/3TC: MK0518B (Raltegravir/3TC) (300mg/150mg) twice daily, administered orally in the 300/150 mg film-coated tablets according to instructions in the prescribing information.
|
Group 2 Standard Combination Therapy
n=25 Participants
NNRTI-Based Regimen:
• EFV/TDF/FTC
PI-Based Regimens:
ATV/r + TDF/FTC or DRV/r + TDF/FTC
INSTI-Based Regimens:
DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC
NNRTI-Based Regimens:
EFV plus ABC/3TC or RPV/TDF/FTC
PI-Based Regimen:
ATV/r plus ABC/3TC
PI-Based Regimens:
DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC
INSTI-Based Regimen:
RAL plus ABC/3TC
And other ART regimens
EFV/TDF/FTC: standard combination therapy
ATV/r + TDF/FTC or DRV/r + TDF/FTC
DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC
EFV plus ABC/3TC or RPV/TDF/FTC
ATV/r plus ABC/3TC
DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC
RAL plus ABC/3TC
Other ART regimens
|
|---|---|---|
|
Changes in Triglycerides
Baseline
|
98.5 mg/dl
Standard Deviation 49.9
|
112.0 mg/dl
Standard Deviation 53.0
|
|
Changes in Triglycerides
Week 24
|
97.7 mg/dl
Standard Deviation 44.8
|
100.9 mg/dl
Standard Deviation 37.3
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Not all the patients performed the DEXA
DEXA
Outcome measures
| Measure |
Group 1 Raltegravir / 3TC (MK0518B
n=47 Participants
Raltegravir / 3TC (MK0518B ) (50 patients)
Raltegravir/3TC: MK0518B (Raltegravir/3TC) (300mg/150mg) twice daily, administered orally in the 300/150 mg film-coated tablets according to instructions in the prescribing information.
|
Group 2 Standard Combination Therapy
n=25 Participants
NNRTI-Based Regimen:
• EFV/TDF/FTC
PI-Based Regimens:
ATV/r + TDF/FTC or DRV/r + TDF/FTC
INSTI-Based Regimens:
DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC
NNRTI-Based Regimens:
EFV plus ABC/3TC or RPV/TDF/FTC
PI-Based Regimen:
ATV/r plus ABC/3TC
PI-Based Regimens:
DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC
INSTI-Based Regimen:
RAL plus ABC/3TC
And other ART regimens
EFV/TDF/FTC: standard combination therapy
ATV/r + TDF/FTC or DRV/r + TDF/FTC
DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC
EFV plus ABC/3TC or RPV/TDF/FTC
ATV/r plus ABC/3TC
DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC
RAL plus ABC/3TC
Other ART regimens
|
|---|---|---|
|
Changes in Bone Mineral Density
Baseline
|
1166.1 gr/cm^2
Standard Deviation 100.9
|
1211.6 gr/cm^2
Standard Deviation 79.6
|
|
Changes in Bone Mineral Density
Week 24
|
1183.0 gr/cm^2
Standard Deviation 98.5
|
1247.4 gr/cm^2
Standard Deviation 80.9
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Some patients did not performed this determination
Outcome measures
| Measure |
Group 1 Raltegravir / 3TC (MK0518B
n=19 Participants
Raltegravir / 3TC (MK0518B ) (50 patients)
Raltegravir/3TC: MK0518B (Raltegravir/3TC) (300mg/150mg) twice daily, administered orally in the 300/150 mg film-coated tablets according to instructions in the prescribing information.
|
Group 2 Standard Combination Therapy
n=7 Participants
NNRTI-Based Regimen:
• EFV/TDF/FTC
PI-Based Regimens:
ATV/r + TDF/FTC or DRV/r + TDF/FTC
INSTI-Based Regimens:
DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC
NNRTI-Based Regimens:
EFV plus ABC/3TC or RPV/TDF/FTC
PI-Based Regimen:
ATV/r plus ABC/3TC
PI-Based Regimens:
DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC
INSTI-Based Regimen:
RAL plus ABC/3TC
And other ART regimens
EFV/TDF/FTC: standard combination therapy
ATV/r + TDF/FTC or DRV/r + TDF/FTC
DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC
EFV plus ABC/3TC or RPV/TDF/FTC
ATV/r plus ABC/3TC
DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC
RAL plus ABC/3TC
Other ART regimens
|
|---|---|---|
|
Changes in Urine Beta-2-microglobulin/Creatinine Ratio
Baseline
|
672.8 mg/g
Standard Deviation 773.3
|
595.3 mg/g
Standard Deviation 948.7
|
|
Changes in Urine Beta-2-microglobulin/Creatinine Ratio
Week 24
|
275.7 mg/g
Standard Deviation 227.2
|
788.5 mg/g
Standard Deviation 1587.3
|
SECONDARY outcome
Timeframe: 24 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 weeksOutcome measures
Outcome data not reported
Adverse Events
Group 1 Raltegravir / 3TC (MK0518B)
Serious events: 3 serious events
Other events: 12 other events
Deaths: 1 deaths
Group 2 Standard Combination Therapy
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1 Raltegravir / 3TC (MK0518B)
n=49 participants at risk
Raltegravir / 3TC (MK0518B ) (50 patients)
Raltegravir/3TC: MK0518B (Raltegravir/3TC) (300mg/150mg) twice daily, administered orally in the 300/150 mg film-coated tablets according to instructions in the prescribing information.
|
Group 2 Standard Combination Therapy
n=25 participants at risk
NNRTI-Based Regimen:
• EFV/TDF/FTC
PI-Based Regimens:
ATV/r + TDF/FTC or DRV/r + TDF/FTC
INSTI-Based Regimens:
DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC
NNRTI-Based Regimens:
EFV plus ABC/3TC or RPV/TDF/FTC
PI-Based Regimen:
ATV/r plus ABC/3TC
PI-Based Regimens:
DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC
INSTI-Based Regimen:
RAL plus ABC/3TC
And other ART regimens
EFV/TDF/FTC: standard combination therapy
ATV/r + TDF/FTC or DRV/r + TDF/FTC
DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC
EFV plus ABC/3TC or RPV/TDF/FTC
ATV/r plus ABC/3TC
DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC
RAL plus ABC/3TC
Other ART regimens
|
|---|---|---|
|
Blood and lymphatic system disorders
Altered blood test
|
2.0%
1/49 • Number of events 1 • 6 months
An adverse event (AE) is any untoward occurrence to the health of a patient or clinical trial subject treated with a medicinal product and which does not necessarily have a causal relationship with this treatment. A total of 75 subjects were randomized. However, in the RAL/3TC group (n=50), one subject was excluded due to consent withdrawal prior to the initiation of medication and therefore did not complete the Baseline (randomization) visit.
|
0.00%
0/25 • 6 months
An adverse event (AE) is any untoward occurrence to the health of a patient or clinical trial subject treated with a medicinal product and which does not necessarily have a causal relationship with this treatment. A total of 75 subjects were randomized. However, in the RAL/3TC group (n=50), one subject was excluded due to consent withdrawal prior to the initiation of medication and therefore did not complete the Baseline (randomization) visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Neoplasia
|
2.0%
1/49 • Number of events 1 • 6 months
An adverse event (AE) is any untoward occurrence to the health of a patient or clinical trial subject treated with a medicinal product and which does not necessarily have a causal relationship with this treatment. A total of 75 subjects were randomized. However, in the RAL/3TC group (n=50), one subject was excluded due to consent withdrawal prior to the initiation of medication and therefore did not complete the Baseline (randomization) visit.
|
0.00%
0/25 • 6 months
An adverse event (AE) is any untoward occurrence to the health of a patient or clinical trial subject treated with a medicinal product and which does not necessarily have a causal relationship with this treatment. A total of 75 subjects were randomized. However, in the RAL/3TC group (n=50), one subject was excluded due to consent withdrawal prior to the initiation of medication and therefore did not complete the Baseline (randomization) visit.
|
|
Blood and lymphatic system disorders
hilar adenopathies and anemia
|
0.00%
0/49 • 6 months
An adverse event (AE) is any untoward occurrence to the health of a patient or clinical trial subject treated with a medicinal product and which does not necessarily have a causal relationship with this treatment. A total of 75 subjects were randomized. However, in the RAL/3TC group (n=50), one subject was excluded due to consent withdrawal prior to the initiation of medication and therefore did not complete the Baseline (randomization) visit.
|
4.0%
1/25 • Number of events 1 • 6 months
An adverse event (AE) is any untoward occurrence to the health of a patient or clinical trial subject treated with a medicinal product and which does not necessarily have a causal relationship with this treatment. A total of 75 subjects were randomized. However, in the RAL/3TC group (n=50), one subject was excluded due to consent withdrawal prior to the initiation of medication and therefore did not complete the Baseline (randomization) visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanoma
|
0.00%
0/49 • 6 months
An adverse event (AE) is any untoward occurrence to the health of a patient or clinical trial subject treated with a medicinal product and which does not necessarily have a causal relationship with this treatment. A total of 75 subjects were randomized. However, in the RAL/3TC group (n=50), one subject was excluded due to consent withdrawal prior to the initiation of medication and therefore did not complete the Baseline (randomization) visit.
|
4.0%
1/25 • Number of events 1 • 6 months
An adverse event (AE) is any untoward occurrence to the health of a patient or clinical trial subject treated with a medicinal product and which does not necessarily have a causal relationship with this treatment. A total of 75 subjects were randomized. However, in the RAL/3TC group (n=50), one subject was excluded due to consent withdrawal prior to the initiation of medication and therefore did not complete the Baseline (randomization) visit.
|
|
Musculoskeletal and connective tissue disorders
Hernia
|
2.0%
1/49 • Number of events 1 • 6 months
An adverse event (AE) is any untoward occurrence to the health of a patient or clinical trial subject treated with a medicinal product and which does not necessarily have a causal relationship with this treatment. A total of 75 subjects were randomized. However, in the RAL/3TC group (n=50), one subject was excluded due to consent withdrawal prior to the initiation of medication and therefore did not complete the Baseline (randomization) visit.
|
0.00%
0/25 • 6 months
An adverse event (AE) is any untoward occurrence to the health of a patient or clinical trial subject treated with a medicinal product and which does not necessarily have a causal relationship with this treatment. A total of 75 subjects were randomized. However, in the RAL/3TC group (n=50), one subject was excluded due to consent withdrawal prior to the initiation of medication and therefore did not complete the Baseline (randomization) visit.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
2.0%
1/49 • Number of events 1 • 6 months
An adverse event (AE) is any untoward occurrence to the health of a patient or clinical trial subject treated with a medicinal product and which does not necessarily have a causal relationship with this treatment. A total of 75 subjects were randomized. However, in the RAL/3TC group (n=50), one subject was excluded due to consent withdrawal prior to the initiation of medication and therefore did not complete the Baseline (randomization) visit.
|
0.00%
0/25 • 6 months
An adverse event (AE) is any untoward occurrence to the health of a patient or clinical trial subject treated with a medicinal product and which does not necessarily have a causal relationship with this treatment. A total of 75 subjects were randomized. However, in the RAL/3TC group (n=50), one subject was excluded due to consent withdrawal prior to the initiation of medication and therefore did not complete the Baseline (randomization) visit.
|
|
Infections and infestations
febrile syndrome
|
0.00%
0/49 • 6 months
An adverse event (AE) is any untoward occurrence to the health of a patient or clinical trial subject treated with a medicinal product and which does not necessarily have a causal relationship with this treatment. A total of 75 subjects were randomized. However, in the RAL/3TC group (n=50), one subject was excluded due to consent withdrawal prior to the initiation of medication and therefore did not complete the Baseline (randomization) visit.
|
4.0%
1/25 • Number of events 1 • 6 months
An adverse event (AE) is any untoward occurrence to the health of a patient or clinical trial subject treated with a medicinal product and which does not necessarily have a causal relationship with this treatment. A total of 75 subjects were randomized. However, in the RAL/3TC group (n=50), one subject was excluded due to consent withdrawal prior to the initiation of medication and therefore did not complete the Baseline (randomization) visit.
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/49 • 6 months
An adverse event (AE) is any untoward occurrence to the health of a patient or clinical trial subject treated with a medicinal product and which does not necessarily have a causal relationship with this treatment. A total of 75 subjects were randomized. However, in the RAL/3TC group (n=50), one subject was excluded due to consent withdrawal prior to the initiation of medication and therefore did not complete the Baseline (randomization) visit.
|
4.0%
1/25 • Number of events 1 • 6 months
An adverse event (AE) is any untoward occurrence to the health of a patient or clinical trial subject treated with a medicinal product and which does not necessarily have a causal relationship with this treatment. A total of 75 subjects were randomized. However, in the RAL/3TC group (n=50), one subject was excluded due to consent withdrawal prior to the initiation of medication and therefore did not complete the Baseline (randomization) visit.
|
Other adverse events
| Measure |
Group 1 Raltegravir / 3TC (MK0518B)
n=49 participants at risk
Raltegravir / 3TC (MK0518B ) (50 patients)
Raltegravir/3TC: MK0518B (Raltegravir/3TC) (300mg/150mg) twice daily, administered orally in the 300/150 mg film-coated tablets according to instructions in the prescribing information.
|
Group 2 Standard Combination Therapy
n=25 participants at risk
NNRTI-Based Regimen:
• EFV/TDF/FTC
PI-Based Regimens:
ATV/r + TDF/FTC or DRV/r + TDF/FTC
INSTI-Based Regimens:
DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC
NNRTI-Based Regimens:
EFV plus ABC/3TC or RPV/TDF/FTC
PI-Based Regimen:
ATV/r plus ABC/3TC
PI-Based Regimens:
DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC
INSTI-Based Regimen:
RAL plus ABC/3TC
And other ART regimens
EFV/TDF/FTC: standard combination therapy
ATV/r + TDF/FTC or DRV/r + TDF/FTC
DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC
EFV plus ABC/3TC or RPV/TDF/FTC
ATV/r plus ABC/3TC
DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC
RAL plus ABC/3TC
Other ART regimens
|
|---|---|---|
|
Infections and infestations
Amigdalitis
|
6.1%
3/49 • Number of events 3 • 6 months
An adverse event (AE) is any untoward occurrence to the health of a patient or clinical trial subject treated with a medicinal product and which does not necessarily have a causal relationship with this treatment. A total of 75 subjects were randomized. However, in the RAL/3TC group (n=50), one subject was excluded due to consent withdrawal prior to the initiation of medication and therefore did not complete the Baseline (randomization) visit.
|
4.0%
1/25 • Number of events 1 • 6 months
An adverse event (AE) is any untoward occurrence to the health of a patient or clinical trial subject treated with a medicinal product and which does not necessarily have a causal relationship with this treatment. A total of 75 subjects were randomized. However, in the RAL/3TC group (n=50), one subject was excluded due to consent withdrawal prior to the initiation of medication and therefore did not complete the Baseline (randomization) visit.
|
|
Psychiatric disorders
Ansiety
|
0.00%
0/49 • 6 months
An adverse event (AE) is any untoward occurrence to the health of a patient or clinical trial subject treated with a medicinal product and which does not necessarily have a causal relationship with this treatment. A total of 75 subjects were randomized. However, in the RAL/3TC group (n=50), one subject was excluded due to consent withdrawal prior to the initiation of medication and therefore did not complete the Baseline (randomization) visit.
|
12.0%
3/25 • Number of events 3 • 6 months
An adverse event (AE) is any untoward occurrence to the health of a patient or clinical trial subject treated with a medicinal product and which does not necessarily have a causal relationship with this treatment. A total of 75 subjects were randomized. However, in the RAL/3TC group (n=50), one subject was excluded due to consent withdrawal prior to the initiation of medication and therefore did not complete the Baseline (randomization) visit.
|
|
Gastrointestinal disorders
Diarrhea
|
2.0%
1/49 • Number of events 1 • 6 months
An adverse event (AE) is any untoward occurrence to the health of a patient or clinical trial subject treated with a medicinal product and which does not necessarily have a causal relationship with this treatment. A total of 75 subjects were randomized. However, in the RAL/3TC group (n=50), one subject was excluded due to consent withdrawal prior to the initiation of medication and therefore did not complete the Baseline (randomization) visit.
|
8.0%
2/25 • Number of events 2 • 6 months
An adverse event (AE) is any untoward occurrence to the health of a patient or clinical trial subject treated with a medicinal product and which does not necessarily have a causal relationship with this treatment. A total of 75 subjects were randomized. However, in the RAL/3TC group (n=50), one subject was excluded due to consent withdrawal prior to the initiation of medication and therefore did not complete the Baseline (randomization) visit.
|
|
Psychiatric disorders
Insomnia
|
8.2%
4/49 • Number of events 4 • 6 months
An adverse event (AE) is any untoward occurrence to the health of a patient or clinical trial subject treated with a medicinal product and which does not necessarily have a causal relationship with this treatment. A total of 75 subjects were randomized. However, in the RAL/3TC group (n=50), one subject was excluded due to consent withdrawal prior to the initiation of medication and therefore did not complete the Baseline (randomization) visit.
|
0.00%
0/25 • 6 months
An adverse event (AE) is any untoward occurrence to the health of a patient or clinical trial subject treated with a medicinal product and which does not necessarily have a causal relationship with this treatment. A total of 75 subjects were randomized. However, in the RAL/3TC group (n=50), one subject was excluded due to consent withdrawal prior to the initiation of medication and therefore did not complete the Baseline (randomization) visit.
|
|
Infections and infestations
Lues
|
2.0%
1/49 • Number of events 1 • 6 months
An adverse event (AE) is any untoward occurrence to the health of a patient or clinical trial subject treated with a medicinal product and which does not necessarily have a causal relationship with this treatment. A total of 75 subjects were randomized. However, in the RAL/3TC group (n=50), one subject was excluded due to consent withdrawal prior to the initiation of medication and therefore did not complete the Baseline (randomization) visit.
|
12.0%
3/25 • Number of events 3 • 6 months
An adverse event (AE) is any untoward occurrence to the health of a patient or clinical trial subject treated with a medicinal product and which does not necessarily have a causal relationship with this treatment. A total of 75 subjects were randomized. However, in the RAL/3TC group (n=50), one subject was excluded due to consent withdrawal prior to the initiation of medication and therefore did not complete the Baseline (randomization) visit.
|
|
Gastrointestinal disorders
Dizziness
|
6.1%
3/49 • Number of events 3 • 6 months
An adverse event (AE) is any untoward occurrence to the health of a patient or clinical trial subject treated with a medicinal product and which does not necessarily have a causal relationship with this treatment. A total of 75 subjects were randomized. However, in the RAL/3TC group (n=50), one subject was excluded due to consent withdrawal prior to the initiation of medication and therefore did not complete the Baseline (randomization) visit.
|
4.0%
1/25 • Number of events 1 • 6 months
An adverse event (AE) is any untoward occurrence to the health of a patient or clinical trial subject treated with a medicinal product and which does not necessarily have a causal relationship with this treatment. A total of 75 subjects were randomized. However, in the RAL/3TC group (n=50), one subject was excluded due to consent withdrawal prior to the initiation of medication and therefore did not complete the Baseline (randomization) visit.
|
|
Infections and infestations
Common cold
|
6.1%
3/49 • Number of events 3 • 6 months
An adverse event (AE) is any untoward occurrence to the health of a patient or clinical trial subject treated with a medicinal product and which does not necessarily have a causal relationship with this treatment. A total of 75 subjects were randomized. However, in the RAL/3TC group (n=50), one subject was excluded due to consent withdrawal prior to the initiation of medication and therefore did not complete the Baseline (randomization) visit.
|
0.00%
0/25 • 6 months
An adverse event (AE) is any untoward occurrence to the health of a patient or clinical trial subject treated with a medicinal product and which does not necessarily have a causal relationship with this treatment. A total of 75 subjects were randomized. However, in the RAL/3TC group (n=50), one subject was excluded due to consent withdrawal prior to the initiation of medication and therefore did not complete the Baseline (randomization) visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place