Trial Outcomes & Findings for A Clinical Trial Comparing the Efficacy of Tenofovir Disoproxil Fumarate/Emtricitabine/Rilpivirine (TDF/FTC/RPV) Versus TDF/FTC/Efavirenz (TDF/FTC/EFV) in Patients With Undetectable Plasma HIV-1 RNA on Current First-line Treatment (NCT NCT01709084)
NCT ID: NCT01709084
Last Updated: 2021-02-11
Results Overview
Percentage of Participants with viral load (plasma HIV-1 RNA levels) less than 400 copies per mL at Week 48, obtained by the modified Food and Drug Administration (FDA) Snapshot method.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
426 participants
Primary outcome timeframe
Week 48
Results posted on
2021-02-11
Participant Flow
Participant milestones
| Measure |
TDF/FTC/RPV
Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
|
TDF/FTC/EFV
Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.
|
|---|---|---|
|
Overall Study
STARTED
|
213
|
213
|
|
Overall Study
Treated
|
213
|
211
|
|
Overall Study
COMPLETED
|
197
|
198
|
|
Overall Study
NOT COMPLETED
|
16
|
15
|
Reasons for withdrawal
| Measure |
TDF/FTC/RPV
Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
|
TDF/FTC/EFV
Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
7
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Adverse Event
|
5
|
0
|
|
Overall Study
Other
|
5
|
3
|
|
Overall Study
Participant Reached a Virologic Endpoint
|
0
|
1
|
|
Overall Study
Not Treated
|
0
|
2
|
Baseline Characteristics
A Clinical Trial Comparing the Efficacy of Tenofovir Disoproxil Fumarate/Emtricitabine/Rilpivirine (TDF/FTC/RPV) Versus TDF/FTC/Efavirenz (TDF/FTC/EFV) in Patients With Undetectable Plasma HIV-1 RNA on Current First-line Treatment
Baseline characteristics by cohort
| Measure |
TDF/FTC/RPV
n=213 Participants
Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
|
TDF/FTC/EFV
n=211 Participants
Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.
|
Total
n=424 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.6 years
STANDARD_DEVIATION 8 • n=5 Participants
|
40.6 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
40.6 years
STANDARD_DEVIATION 8.34 • n=5 Participants
|
|
Sex: Female, Male
Female
|
137 Participants
n=5 Participants
|
134 Participants
n=7 Participants
|
271 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
153 Participants
n=5 Participants
|
|
Region of Enrollment
CAMEROON
|
16 participants
n=5 Participants
|
13 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Region of Enrollment
KENYA
|
36 participants
n=5 Participants
|
37 participants
n=7 Participants
|
73 participants
n=5 Participants
|
|
Region of Enrollment
SENEGAL
|
17 participants
n=5 Participants
|
8 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Region of Enrollment
SOUTH AFRICA
|
33 participants
n=5 Participants
|
30 participants
n=7 Participants
|
63 participants
n=5 Participants
|
|
Region of Enrollment
THAILAND
|
51 participants
n=5 Participants
|
58 participants
n=7 Participants
|
109 participants
n=5 Participants
|
|
Region of Enrollment
UGANDA
|
60 participants
n=5 Participants
|
65 participants
n=7 Participants
|
125 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 48Population: The intent-to-treat (ITT) population included all participants who were randomized and who had taken at least 1 dose of study drug.
Percentage of Participants with viral load (plasma HIV-1 RNA levels) less than 400 copies per mL at Week 48, obtained by the modified Food and Drug Administration (FDA) Snapshot method.
Outcome measures
| Measure |
TDF/FTC/RPV
n=213 Participants
Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
|
TDF/FTC/EFV
n=211 Participants
Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.
|
|---|---|---|
|
Percentage of Participants With Plasma Human Immunodeficiency Virus - Type 1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than (<) 400 Copies Per Milliliter (Copies/mL) at Week 48
|
93.9 Percentage of Participants
Interval -6.44 to
|
96.2 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 48Population: The intent-to-treat (ITT) population included all participants who were randomized and who had taken at least 1 dose of study drug.
Percentage of Participants with plasma HIV-1 RNA \<50 copies/mL, obtained by the modified Food and Drug Administration (FDA) Snapshot method.
Outcome measures
| Measure |
TDF/FTC/RPV
n=213 Participants
Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
|
TDF/FTC/EFV
n=211 Participants
Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.
|
|---|---|---|
|
Percentage of Participants With Plasma HIV-1 RNA Levels < 50 Copies/mL at Week 48
|
93.9 Percentage of Participants
|
96.2 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 48Population: The intent-to-treat (ITT) population included all participants who were randomized and who had taken at least 1 dose of study drug. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Percentage of participants with plasma HIV-1 RNA levels analysed based on time to loss of virologic response (TLOVR) imputation method which is defined as confirmed plasma HIV-1 RNA \>=400 copies/mL, excluding participants who discontinued the study with HIV-1 RNA suppression \<400 copies/mL.
Outcome measures
| Measure |
TDF/FTC/RPV
n=201 Participants
Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
|
TDF/FTC/EFV
n=205 Participants
Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.
|
|---|---|---|
|
Percentage of Participants With Plasma HIV-1 RNA Levels More Than or Equal to (>=) 400 Copies/mL at Week 48 Based on Time to Loss of Virologic Response (TLOVR) [Non-virologic Failure Censored] Imputation Method.
|
0.5 Percentage of Participants
|
0.5 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 48Population: The intent-to-treat (ITT) population included all participants who were randomized and who had taken at least 1 dose of study drug. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Percentage of participants with plasma HIV-1 RNA levels analysed based on TLOVR imputation method which is defined as confirmed plasma HIV-1 RNA \>=50 copies/mL, excluding participants who discontinued the study with HIV-1 RNA suppression \<50 copies/mL.
Outcome measures
| Measure |
TDF/FTC/RPV
n=201 Participants
Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
|
TDF/FTC/EFV
n=205 Participants
Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.
|
|---|---|---|
|
Percentage of Participants With Plasma HIV-1 RNA Levels >= 50 Copies Per Milliliter (Copies/mL) at Week 48 Based on Time to Loss of Virologic Response (TLOVR) [Non-virologic Failure Censored] Imputation Method.
|
1.5 Percentage of Participants
|
1.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to 48 WeeksPopulation: The intent-to-treat (ITT) population included all participants who were randomized and who had taken at least 1 dose of study drug. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
In both treatment groups adherence rates assessed by tablet count, the majority of participants had an adherence of \>95% (97% and 98% in RPV and EFV treated treatment groups respectively).
Outcome measures
| Measure |
TDF/FTC/RPV
n=207 Participants
Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
|
TDF/FTC/EFV
n=206 Participants
Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.
|
|---|---|---|
|
Percentage of Participant With Treatment Adherence Based on Tablet Count
|
97.2 Percentage of Participants
1.981
|
97.6 Percentage of Participants
1.649
|
SECONDARY outcome
Timeframe: Up to Week 48Population: The intent-to-treat (ITT) population included all participants who were randomized and who had taken at least 1 dose of study drug.
To compare the loss of treatment options, the number of participants with treatment-emergent N\[t\]RTI or NNRTI mutations, as defined by IAS-USA (2014), after virologic failure were compared between the treatment groups.
Outcome measures
| Measure |
TDF/FTC/RPV
n=213 Participants
Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
|
TDF/FTC/EFV
n=211 Participants
Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Nucleoside Reverse Transcriptase Inhibitor (N[t]RTI) or Nucleoside/Nucleotide Reverse Transcriptase Inhibitor (NNRTI) Mutations
|
0 Participants
|
0 Participants
|
Adverse Events
TDF/FTC/RPV
Serious events: 16 serious events
Other events: 128 other events
Deaths: 0 deaths
TDF/FTC/EFV
Serious events: 11 serious events
Other events: 137 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TDF/FTC/RPV
n=213 participants at risk
Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
|
TDF/FTC/EFV
n=211 participants at risk
Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/213
|
0.47%
1/211
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/213
|
0.47%
1/211
|
|
Cardiac disorders
Myocardial Infarction
|
0.47%
1/213
|
0.00%
0/211
|
|
Gastrointestinal disorders
Gastrointestinal Inflammation
|
0.00%
0/213
|
0.47%
1/211
|
|
Immune system disorders
Food Allergy
|
0.00%
0/213
|
0.47%
1/211
|
|
Infections and infestations
Appendicitis
|
0.47%
1/213
|
0.00%
0/211
|
|
Infections and infestations
Gastroenteritis
|
0.47%
1/213
|
0.00%
0/211
|
|
Infections and infestations
Influenza
|
0.47%
1/213
|
0.00%
0/211
|
|
Infections and infestations
Neurocysticercosis
|
0.47%
1/213
|
0.00%
0/211
|
|
Infections and infestations
Neurosyphilis
|
0.47%
1/213
|
0.00%
0/211
|
|
Infections and infestations
Pneumonia
|
0.47%
1/213
|
0.00%
0/211
|
|
Infections and infestations
Sinusitis
|
0.00%
0/213
|
0.47%
1/211
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.47%
1/213
|
0.00%
0/211
|
|
Investigations
Alanine Aminotransferase Increased
|
0.47%
1/213
|
0.00%
0/211
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
1.4%
3/213
|
0.00%
0/211
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.94%
2/213
|
0.00%
0/211
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/213
|
0.47%
1/211
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix Carcinoma
|
0.00%
0/213
|
0.47%
1/211
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyoma
|
0.47%
1/213
|
0.00%
0/211
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous
|
0.94%
2/213
|
0.47%
1/211
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.00%
0/213
|
0.47%
1/211
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/213
|
0.47%
1/211
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/213
|
0.47%
1/211
|
|
Reproductive system and breast disorders
Uterine Haemorrhage
|
0.00%
0/213
|
0.47%
1/211
|
Other adverse events
| Measure |
TDF/FTC/RPV
n=213 participants at risk
Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
|
TDF/FTC/EFV
n=211 participants at risk
Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
3.8%
8/213
|
5.7%
12/211
|
|
Ear and labyrinth disorders
Vertigo
|
5.2%
11/213
|
9.0%
19/211
|
|
Gastrointestinal disorders
Diarrhoea
|
3.8%
8/213
|
5.2%
11/211
|
|
Infections and infestations
Malaria
|
4.7%
10/213
|
10.4%
22/211
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
29.6%
63/213
|
28.0%
59/211
|
|
Infections and infestations
Urinary Tract Infection
|
13.6%
29/213
|
13.3%
28/211
|
|
Investigations
Amylase Increased
|
6.6%
14/213
|
2.4%
5/211
|
|
Investigations
Blood Pressure Increased
|
6.1%
13/213
|
4.3%
9/211
|
|
Metabolism and nutrition disorders
Increased Appetite
|
5.2%
11/213
|
1.4%
3/211
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.0%
17/213
|
7.1%
15/211
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
9.4%
20/213
|
6.6%
14/211
|
|
Nervous system disorders
Dizziness
|
3.3%
7/213
|
6.6%
14/211
|
|
Nervous system disorders
Headache
|
17.8%
38/213
|
13.7%
29/211
|
|
Nervous system disorders
Somnolence
|
5.2%
11/213
|
1.4%
3/211
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.9%
19/213
|
3.3%
7/211
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.6%
14/213
|
4.7%
10/211
|
|
Vascular disorders
Hypertension
|
2.3%
5/213
|
6.2%
13/211
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER