18 and older, any sex, with Infection, Human Immunodeficiency Virus or HIV Infections. 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 With Plasma Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) < 50 Copies/Milliliter at Week 48 in DTG Arm Using the Modified United States (US) Food and Drug Administration (FDA) Snapshot AlgorithmPrimary· Week 48
Plasma samples were collected for quantitative analysis of HIV-1 RNA. The percentage of participants with plasma HIV-1 RNA \<50 copies/milliliter was assessed at Week 48 using the snapshot algorithm in the DTG arm. Response was assessed using a modified FDA Snapshot algorithm in which participants were not penalized for any single protocol allowed background therapy substitution even if occurs after the first trial visit. In this approach participants with HIV-1 RNA \>=50 copies/milliliter are considered as non-responders. Participants without HIV-1 RNA data at Week 48 (due to missing data or
Group
Value
95% CI
DTG 50 mg
75
65 – 86
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/Milliliter at Week 48 in EFV Arm Using the Modified Snapshot AlgorithmSecondary· Week 48
Plasma samples were collected for quantitative analysis of HIV-1 RNA. The percentage of participants with plasma HIV-1 RNA \<50 copies/milliliter were assessed at Week 48 using the snapshot algorithm in the EFV arm. Response was assessed using a modified FDA Snapshot algorithm in which participants were not penalized for any single protocol allowed background therapy substitution even if occurs after the first trial visit. In this approach participants with HIV-1 RNA \>=50 copies/milliliter are considered as non-responders. Participants without HIV-1 RNA data at Week 48 (due to missing data or
Group
Value
95% CI
EFV 600 mg
82
70 – 93
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/Milliliter at Week 24 in Both EFV and DTG Arms Using the Modified Snapshot AlgorithmSecondary· Week 24
Plasma samples were collected for quantitative analysis of HIV-1 RNA. The percentage of participants with plasma HIV-1 RNA \<50 copies/milliliter were assessed at Week 24 using the snapshot algorithm in the DTG and EFV arm. Response was assessed according to the Modified Snapshot algorithm. In this approach participants with HIV-1 RNA \>=50 copies/milliliter were considered non-responders. Participants without HIV-1 RNA data at Week 24 (due to missing data or discontinuation of IP prior to visit window) were also considered as non-responders, as well as participants with ART substitutions were
Group
Value
95% CI
DTG 50 mg
81
72 – 90
EFV 600 mg
89
79 – 98
Percentage of Participants Without Confirmed Virologic Withdrawal and Without Discontinuation Due to Treatment-related Reasons at Week 24 and Week 48Secondary· Week 24 and Week 48
Percentage of participants not meeting confirmed virologic withdrawal criteria nor discontinued due to treatment related reasons at the time of analysis at Week 24 (through Day 210) and Week 48 (through Day 350) has been presented by treatment group. The time to meeting confirmed virologic withdrawal criteria or discontinuation due to treatment related reasons (i.e., discontinuation due to drug-related adverse event \[AE\], or due to protocol defined safety stopping criteria, or due to lack of efficacy) were calculated. Participants who met confirmed virologic withdrawal criteria or discontinu
Week 24
Group
Value
95% CI
DTG 50 mg
98.4
89.1 – 99.8
EFV 600 mg
95.2
82.1 – 98.8
Week 48
Group
Value
95% CI
DTG 50 mg
96.6
87.0 – 99.1
EFV 600 mg
92.7
79.1 – 97.6
Change From Baseline in Cluster of Differentiation 4 (CD4+) Counts at Week 24 and Week 48Secondary· Baseline (Day 1), Week 24 and Week 48
Blood samples were collected for assessment of lymphocyte subsets (CD4+ lymphocyte count) by flow cytometry at Baseline and Weeks 24, 48. Baseline was defined as the last pre-treatment value observed (typically from Day 1 visit). Change from Baseline was calculated subtracting the value at the specified time point from the Baseline value.
Week 24, n=61,41
Group
Value
95% CI
DTG 50 mg
153.2
± 125.09
EFV 600 mg
127.1
± 158.14
Week 48, n=49, 33
Group
Value
95% CI
DTG 50 mg
199.0
± 146.22
EFV 600 mg
194.5
± 137.81
Number of Participants With Serious Adverse Event (SAE) and Common (>=5%) Non-serious AE (Non-SAE) - Randomized PhaseSecondary· Up to Week 52
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward medical occurrence that, at any dose that results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, all events of possible drug-induced liver injury with hyperbilirubinemia or any other situation according to medical or scienti
Common Non-SAE
Group
Value
95% CI
DTG 50 mg
38
EFV 600 mg
33
SAE
Group
Value
95% CI
DTG 50 mg
5
EFV 600 mg
5
Number of Participants With SAE and Common (>=5%) Non-SAE - OLE PhaseSecondary· Week 52 to Week 252
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward medical occurrence that, at any dose that results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, all events of possible drug-induced liver injury with hyperbilirubinemia or any other situation according to medical or scienti
Common Non-SAE
Group
Value
95% CI
DTG 50 mg
36
EFV 600 mg
16
SAE
Group
Value
95% CI
DTG 50 mg
5
EFV 600 mg
2
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized PhaseSecondary· Up to Week 52
Blood samples for assessment of clinical chemistry parameters were collected at indicated time points. Clinical chemistry assessments included alanine aminotransferase (ALT), albumin, alkaline phosphatase, aspartate aminotransferase (AST), bilirubin, carbon dioxide, cholesterol, creatine kinase, creatinine, glucose, low density lipoprotein (LDL) cholesterol calculation, lipase, phosphate, potassium, and sodium. Data for number of participants who experienced maximum post-Baseline emergent chemistry toxicities were summarized. Maximum post-Baseline emergent chemistry toxicities were graded usin
ALT, Grade 1
Group
Value
95% CI
DTG 50 mg
10
EFV 600 mg
9
ALT, Grade 2
Group
Value
95% CI
DTG 50 mg
1
EFV 600 mg
1
ALT, Grade 3
Group
Value
95% CI
DTG 50 mg
1
EFV 600 mg
1
ALT, Grade 4
Group
Value
95% CI
DTG 50 mg
0
EFV 600 mg
0
Albumin, Grade 1
Group
Value
95% CI
DTG 50 mg
2
EFV 600 mg
2
Albumin, Grade 2
Group
Value
95% CI
DTG 50 mg
8
EFV 600 mg
1
Albumin, Grade 3
Group
Value
95% CI
DTG 50 mg
0
EFV 600 mg
0
Albumin, Grade 4
Group
Value
95% CI
DTG 50 mg
0
EFV 600 mg
0
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE PhaseSecondary· Up to Week 252
Blood samples for assessment of clinical chemistry parameters were collected at indicated time points. Clinical chemistry assessments included ALT, albumin, alkaline phosphatase, AST, bilirubin, carbon dioxide, cholesterol, creatine kinase, creatinine, glucose, LDL cholesterol calculation, lipase, phosphate, potassium, and sodium. Data for number of participants with maximum post-Baseline emergent chemistry toxicities were summarized. Maximum post-Baseline emergent chemistry toxicities were graded using DAIDS toxicity grading for HIV-infected participants as Grade 1 (mild), Grade 2 (moderate),
ALT, Grade 1
Group
Value
95% CI
DTG 50 mg
12
EFV 600 mg
10
ALT, Grade 2
Group
Value
95% CI
DTG 50 mg
3
EFV 600 mg
2
ALT, Grade 3
Group
Value
95% CI
DTG 50 mg
1
EFV 600 mg
1
ALT, Grade 4
Group
Value
95% CI
DTG 50 mg
0
EFV 600 mg
0
Albumin, Grade 1
Group
Value
95% CI
DTG 50 mg
2
EFV 600 mg
2
Albumin, Grade 2
Group
Value
95% CI
DTG 50 mg
8
EFV 600 mg
1
Albumin, Grade 3
Group
Value
95% CI
DTG 50 mg
0
EFV 600 mg
0
Albumin, Grade 4
Group
Value
95% CI
DTG 50 mg
0
EFV 600 mg
0
Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized PhaseSecondary· Up to Week 52
Blood samples for assessment of hematology parameters were collected at indicated time points. Hematology assessments included hemoglobin, leukocytes, neutrophils and platelets. Data for number of participants who experienced maximum post-Baseline emergent hematology toxicities were summarized. Maximum post-Baseline emergent hematology toxicities were graded using DAIDS toxicity grading for HIV-infected participants as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life-threating). Higher grade indicates more severity.
Hemoglobin, Grade 1
Group
Value
95% CI
DTG 50 mg
2
EFV 600 mg
1
Hemoglobin, Grade 2
Group
Value
95% CI
DTG 50 mg
0
EFV 600 mg
0
Hemoglobin, Grade 3
Group
Value
95% CI
DTG 50 mg
0
EFV 600 mg
0
Hemoglobin, Grade 4
Group
Value
95% CI
DTG 50 mg
0
EFV 600 mg
0
Leukocytes, Grade 1
Group
Value
95% CI
DTG 50 mg
4
EFV 600 mg
1
Leukocytes, Grade 2
Group
Value
95% CI
DTG 50 mg
0
EFV 600 mg
0
Leukocytes, Grade 3
Group
Value
95% CI
DTG 50 mg
0
EFV 600 mg
1
Leukocytes, Grade 4
Group
Value
95% CI
DTG 50 mg
0
EFV 600 mg
1
Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE PhaseSecondary· Up to Week 252
Blood samples for assessment of hematology parameters were collected at indicated time points. Hematology assessments included hemoglobin, leukocytes, neutrophils and platelets. Data for number of participants who experienced maximum post-Baseline emergent hematology toxicities were summarized. Maximum post-Baseline emergent hematology toxicities were graded using DAIDS toxicity grading for HIV-infected participants as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life-threating). Higher grade indicates more severity.
Hemoglobin, Grade 1
Group
Value
95% CI
DTG 50 mg
2
EFV 600 mg
1
Hemoglobin, Grade 2
Group
Value
95% CI
DTG 50 mg
1
EFV 600 mg
0
Hemoglobin, Grade 3
Group
Value
95% CI
DTG 50 mg
0
EFV 600 mg
0
Hemoglobin, Grade 4
Group
Value
95% CI
DTG 50 mg
0
EFV 600 mg
0
Leukocytes, Grade 1
Group
Value
95% CI
DTG 50 mg
5
EFV 600 mg
3
Leukocytes, Grade 2
Group
Value
95% CI
DTG 50 mg
1
EFV 600 mg
1
Leukocytes, Grade 3
Group
Value
95% CI
DTG 50 mg
0
EFV 600 mg
1
Leukocytes, Grade 4
Group
Value
95% CI
DTG 50 mg
0
EFV 600 mg
1
Percent Change From Baseline in the Fasting Lipid Profile at Week 24 and Week 48Secondary· Baseline (Day 1), Week 24 and Week 48
Samples for lipid measurements were obtained in a fasted state at Baseline, Week 24 and Week 48. The parameters assessed during the lipid profile were total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, triglycerides. Baseline was defined as the last pre-treatment value observed (typically from Day 1 visit). Percent change from Baseline for a parameter was calculated as the observed value minus the Baseline value divided by Baseline value multiplied by 100. Data for fasting lipid parameters has been summarized.
Cholesterol, Week 24, n=58, 40
Group
Value
95% CI
DTG 50 mg
6.314
± 20.7036
EFV 600 mg
16.443
± 22.0445
Cholesterol, Week 48, n=47, 34
Group
Value
95% CI
DTG 50 mg
-0.375
± 21.4890
EFV 600 mg
17.371
± 20.6312
HDL Cholesterol, Week 24, n=58, 40
Group
Value
95% CI
DTG 50 mg
39.002
± 53.5060
EFV 600 mg
39.174
± 49.1087
HDL Cholesterol, Week 48, n=47, 34
Group
Value
95% CI
DTG 50 mg
24.987
± 48.2471
EFV 600 mg
45.423
± 52.9949
LDL Cholesterol, Week 24, n=58, 40
Group
Value
95% CI
DTG 50 mg
4.315
± 31.7095
EFV 600 mg
13.487
± 36.2511
LDL Cholesterol, Week 48, n=47, 34
Group
Value
95% CI
DTG 50 mg
-2.957
± 31.9910
EFV 600 mg
9.132
± 41.1942
Triglycerides, Week 24, n=58, 40
Group
Value
95% CI
DTG 50 mg
-22.744
± 33.4148
EFV 600 mg
16.934
± 118.7319
Triglycerides, Week 48, n=47, 34
Group
Value
95% CI
DTG 50 mg
-18.402
± 39.0227
EFV 600 mg
13.175
± 57.0389
Adverse events — posted to ClinicalTrials.gov
Time frame: Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
HIV/Tuberculosis (TB) co-infection have profound effects on the host's immune system. TB is the most common cause of death in patients with HIV worldwide. Rifamycins (such as rifampicin \[RIF\]) are an important component of TB therapy because of their unique activity. The problem is that most protease inhibitors (PI) and non-nucleoside reverse transcriptase inhibitors (NNRTI) used to treat HIV have significant drug-drug interactions with RIF that can lead to reduced concentrations of these agents with risk of treatment failure or resistance. The non-nucleoside reverse transcriptase inhibitor (NNRTI) efavirenz (EFV) does not present the same significant drug interactions with RIF. EFV-based HIV treatment was tested in patients concomitantly treated with RIF-containing TB therapy, demonstrating that their co-administration can be used safely and effectively. However, the side effect profile of EFV overlaps with the RIF-containing TB regimens and makes the management of treatment toxicities very complex. Integrase inhibitors (INI), such as dolutegravir (DTG), may offer an important alternative to EFV-based therapy in TB coinfected patients. A Phase I drug-drug interaction study was conducted in healthy, HIV-seronegative subjects, and showed that DTG at 50 mg twice daily given together with RIF was well-tolerated and resulted in DTG concentrations similar to those of DTG 50 mg given once daily alone, which is the recommended dose for INI-naive patients. Therefore, ART regimens using DTG 50 mg twice daily may represent a new treatment option for TB-infected patients who require concurrent treatment for HIV infection. This is a Phase III b, randomized, open-label study describing the efficacy and safety of DTG and EFV-containing ART regimens in HIV/TB co-infected patients. This study is designed to assess the antiviral activity of DTG or efavirenz (EFV) ART-containing regimens through 48 weeks. A total of approximately 115 +/-5% subjects will be randomly assigned in a 3:2 ratio to DTG (approximately 69 subjects) and EFV (approximately 46 subjects), respectively. This study will include a Screening Period, a Randomized Phase (Day 1 to 48 weeks plus a 4-week extension), and a DTG Open-label extension (OLE). During the DTG OLE, subjects will be supplied with DTG until it is locally approved and commercially available, the subject no longer derives clinical benefit, or the subject meets a protocol-defined reason for discontinuation, which ever comes first.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
NCT02422797 — Regimen Switch to Dolutegravir + Rilpivirine From Current Antiretroviral Regimen in Human Immunodeficiency Virus Type 1
· Phase 3
· completed
NCT02429791 — Regimen Switch to Dolutegravir + Rilpivirine From Current Antiretroviral Regimen in Human Immunodeficiency Virus Type 1
· Phase 3
· completed
Other recruiting trials for Infection, Human Immunodeficiency Virus
Currently open trials in the same condition.
NCT02951052 — Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpiv
· Phase 3
· active not recruiting
Other ViiV Healthcare trials
Trials by the same sponsor.
NCT07393659 — A Continued Access Study for Participants Transitioning From ViiV Healthcare-sponsored or ViiV Healthcare-collaborative
· Phase 3
· not yet recruiting
NCT07525544 — A Study to Investigate the Safety and PK of VH4770359 in Healthy Participants
· Phase 1
· not yet recruiting
NCT07275606 — A Study to Investigate Cabotegravir for Neonates Exposed to HIV-1
· Phase 1, PHASE2
· not yet recruiting
NCT07202546 — A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study)
· Phase 2
· recruiting
NCT07053384 — A Study to Investigate the Use of VH3810109 With or Without Fostemsavir (FTR) to Reduce the Size and Activity of the Vir
· Phase 1
· active not recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by ViiV Healthcare
Last refreshed: 12 January 2021
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/NCT02178592.