SALIF: 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

• Sponsor: Janssen-Cilag International NV (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01709084
• Collaborator: (none)
• Enrollment: 426
• Locations: 18
• Arms: 2
• Actual Duration (Months): 81
• Patients Per Site: 23.7
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The purpose of this study is to demonstrate noninferiority (a new treatment is equivalent to standard treatment) in terms of the percentage of patients who have plasma human immunodeficiency virus-type 1 (HIV-1) ribonucleic acid (RNA) levels less than 400 copies per mL after 48 weeks of randomized treatment with tenofovir disoproxil fumarate/emtricitabine/rilpivirine (TDF/FTC/RPV) versus TDF/FTC/efavirenz (TDF/FTC/EFV).

Condition or Disease	Intervention/Treatment	Phase
Human Immunodeficiency Virus-type 1 Infection	Drug: Rilpivirine; Drug: Efavirenz; Drug: Tenofovir disoproxil fumarate; Drug: Emtricitabine	Phase 3

Detailed Description

This is a 48-week, multicenter (study conducted at multiple sites), multinational (conducted at different countries), open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance) study to assess whether tenofovir disoproxil fumarate/emtricitabine/rilpivirine (TDF/FTC/RPV) shows noninferior response rates of human immunodeficiency virus-type 1 (HIV-1) ribonucleic acid (RNA) suppression less than 400 copies per mL, compared with TDF/FTC/efavirenz (TDF/FTC/EFV). The study consists of 3 phases including, the screening phase (of 6 weeks), treatment phase (of 48 weeks), and follow up phase (of 30 to 35 days after the last dose of study medication). During the 48 weeks treatment phase, patients currently with HIV-1 RNA suppression less than 50 copies per mL on their first-line antiretroviral regimen, will be randomized in a 1:1 ratio, in 2 groups, ie, Group 1 (treatment group) and Group 2 (control group). Both these groups will receive a fixed dose combination (FDC) regimen (ie, FDC tablet: one tablet per day) of either TDF/FTC/RPV in Group 1 or TDF/FTC/EFV in Group 2. Patients will return for study visits at Week 4, 12, 24, 36, and 48 during the treatment period, and then every 24 weeks thereafter during the extended treatment period until the last patient has his or her Week 48 (or treatment discontinuation) visit. Safety evaluations for adverse events, clinical laboratory (central and local) tests, electrocardiogram, vital signs, and physical examination will be performed throughout the study. The treatment duration for each patient will be expected to be between 48 and 108 weeks.

Study Design

• Study Type: Interventional
• Actual Enrollment: 426 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 3b, Randomized, Open-label Clinical Study to Demonstrate Non-inferiority in Virologic Response Rates of HIV-1 RNA Suppression <400 Copies/mL of TDF/FTC/RPV Versus TDF/FTC/EFV in First-line Antiretroviral NNRTI-based Suppressed Patients. Switching At Low HIV-1 RNA Into Fixed Dose Combinations (SALIF)
• Actual Study Start Date: Oct 2, 2013
• Actual Primary Completion Date: Oct 22, 2015
• Actual Study Completion Date: Jul 2, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 Patients will receive fixed dose combination (FDC) tablet of tenofovir disoproxil fumarate/emtricitabine/rilpivirine with a meal, until Week 48.	Drug: Rilpivirine; Type=exact number, unit=mg, number=25, form=tablet, route=oral. Rilpivirine will be administered in a fixed dose combination along with tenofovir disoproxil fumarate and emtricitabine, as a single dose tablet.; Other Names: EDURANT ; Drug: Tenofovir disoproxil fumarate; Type=exact number, unit=mg, number=300, form=tablet, route=oral. Tenofovir disoproxil fumarate will be administered in a fixed dose combination along with rilpivirine and emtricitabine in Group 1, and along with efavirenz and emtricitabine in Group 2.; Drug: Emtricitabine; Type=exact number, unit=mg, number=200, form=tablet, route=oral. Emtricitabine will be administered in a fixed dose combination along with rilpivirine and tenofovir disoproxil fumarate in Group 1, and along with efavirenz and tenofovir disoproxil fumarate in Group 2.
Active Comparator: Group 2 Patients will receive FDC tablet of tenofovir disoproxil fumarate/emtricitabine /efavirenz on an empty stomach at bedtime, until Week 48.	Drug: Efavirenz; Type=exact number, unit=mg, number=600, form=tablet, route=oral. Efavirenz will be administered in a fixed dose combination along with tenofovir disoproxil fumarate and emtricitabine, as a single dose tablet.; Drug: Tenofovir disoproxil fumarate; Type=exact number, unit=mg, number=300, form=tablet, route=oral. Tenofovir disoproxil fumarate will be administered in a fixed dose combination along with rilpivirine and emtricitabine in Group 1, and along with efavirenz and emtricitabine in Group 2.; Drug: Emtricitabine; Type=exact number, unit=mg, number=200, form=tablet, route=oral. Emtricitabine will be administered in a fixed dose combination along with rilpivirine and tenofovir disoproxil fumarate in Group 1, and along with efavirenz and tenofovir disoproxil fumarate in Group 2.

Outcome Measures

Primary Outcome Measures

1. 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 [Week 48]

   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.

Secondary Outcome Measures

1. Percentage of Participants With Plasma HIV-1 RNA Levels < 50 Copies/mL at Week 48 [Week 48]

   Percentage of Participants with plasma HIV-1 RNA <50 copies/mL, obtained by the modified Food and Drug Administration (FDA) Snapshot method.

2. 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. [Week 48]

   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.

3. 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. [Week 48]

   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.

4. Percentage of Participant With Treatment Adherence Based on Tablet Count [Up to 48 Weeks]

   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).

5. Number of Participants With Treatment-Emergent Nucleoside Reverse Transcriptase Inhibitor (N[t]RTI) or Nucleoside/Nucleotide Reverse Transcriptase Inhibitor (NNRTI) Mutations [Up to Week 48]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Documented human immunodeficiency virus-type 1 (HIV-1) infection Patients who have been receiving first line highly active antiretroviral therapy (HAART) for at least 1 year before the screening visit Patients who have been taking the same ARV combination for at least 8 weeks before the screening visit and are expected to continue on this regimen throughout the screening period.

Patients who prefer to change the current HAART regimen for reasons of simplification and/or toxicity of nucleoside/nucleotide reverse transcriptase inhibitor (N[t]RTI) Plasma HIV-1 RNA less than 50 copies per mL and CD4+ cell count higher than 200 per mm3 at the screening visit Agrees to protocol-defined use of effective contraception

Exclusion Criteria:

History of virologic failure (2 consecutive plasma HIV-1 ribonucleic acid (RNA) more than or equal to 400 copies per mL) while on previous or current ART History of immunologic failure (2 consecutive CD4+ cell counts during HAART treatment falling below the pre-HAART level) History of any primary N[t]RTI or NNRTI mutations Has a previously documented HIV-2 infection Significantly decreased hepatic function or hepatic insufficiency or diagnosed with acute clinical viral hepatitis Diagnosed with Mycobacterium tuberculosis infection Severe laboratory abnormalities Creatinine clearance less than 50 mL per minute Addicted to drug, including alcohol or recreational drugs

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Douala		Cameroon
2		Yaounde		Cameroon
3		Eldoret		Kenya
4		Kangemi, Nairobi		Kenya
5		Nairobi		Kenya
6		Nyanza		Kenya
7		Dakar		Senegal
8		Pikine		Senegal
9		Bloemfontein		South Africa
10		Johannesburg		South Africa
11		Soweto		South Africa
12		Wentworth, Durban		South Africa
13		Westville, KwaZulu		South Africa
14		Amphur Mueang Nonthaburi		Thailand
15		Bangkok		Thailand
16		Chiang Mai		Thailand
17		Entebbe		Uganda
18		Kampala		Uganda

Sponsors and Collaborators

• Janssen-Cilag International NV

Investigators

• Study Director: Janssen-Cilag International NV Clinical Trial, Janssen-Cilag International NV

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Janssen-Cilag International NV
• ClinicalTrials.gov Identifier: NCT01709084
• Other Study ID Numbers: CR100875; TMC278IFD3002
• First Posted: Oct 17, 2012
• Last Update Posted: Feb 11, 2021
• Last Verified: Jan 1, 2021

• Keywords provided by Janssen-Cilag International NV: Human immunodeficiency virus-type 1 infection; HIV-1; Infectious diseases; Ribonucleic acid; RNA; Tenofovir disoproxil fumarate; Emtricitabine; Rilpivirine; Efavirenz; Edurant; TMC278; R278474; Fixed dose combination
• Additional relevant MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes; Tenofovir; Emtricitabine; Efavirenz; Rilpivirine

Study Results

Participant Flow

Arm/Group Title	TDF/FTC/RPV	TDF/FTC/EFV
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	213	213
Treated	213	211
COMPLETED	197	198
NOT COMPLETED	16	15

Baseline Characteristics

Arm/Group Title	TDF/FTC/RPV	TDF/FTC/EFV	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	213	211	424
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	40.6 (8)	40.6 (8.7)	40.6 (8.34)
Sex: Female, Male (Count of Participants)
Female	137 64.3%	134 63.5%	271 63.9%
Male	76 35.7%	77 36.5%	153 36.1%
Region of Enrollment (participants) [Number]
CAMEROON	16 7.5%	13 6.2%	29 6.8%
KENYA	36 16.9%	37 17.5%	73 17.2%
SENEGAL	17 8%	8 3.8%	25 5.9%
SOUTH AFRICA	33 15.5%	30 14.2%	63 14.9%
THAILAND	51 23.9%	58 27.5%	109 25.7%
UGANDA	60 28.2%	65 30.8%	125 29.5%

Outcome Measures

1. Primary Outcome

Title	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
Description	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.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

The intent-to-treat (ITT) population included all participants who were randomized and who had taken at least 1 dose of study drug.

Arm/Group Title	TDF/FTC/RPV	TDF/FTC/EFV
Arm/Group Description	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.	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.
Measure Participants	213	211
Number [Percentage of Participants]	93.9 44.1%	96.2 45.6%

2. Secondary Outcome

Title	Percentage of Participants With Plasma HIV-1 RNA Levels < 50 Copies/mL at Week 48
Description	Percentage of Participants with plasma HIV-1 RNA <50 copies/mL, obtained by the modified Food and Drug Administration (FDA) Snapshot method.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

The intent-to-treat (ITT) population included all participants who were randomized and who had taken at least 1 dose of study drug.

Arm/Group Title	TDF/FTC/RPV	TDF/FTC/EFV
Arm/Group Description	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.	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.
Measure Participants	213	211
Number [Percentage of Participants]	93.9 44.1%	96.2 45.6%

3. Secondary Outcome

Title	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.
Description	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.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	TDF/FTC/RPV	TDF/FTC/EFV
Arm/Group Description	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.	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.
Measure Participants	201	205
Number [Percentage of Participants]	0.5 0.2%	0.5 0.2%

4. Secondary Outcome

Title	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.
Description	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.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	TDF/FTC/RPV	TDF/FTC/EFV
Arm/Group Description	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.	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.
Measure Participants	201	205
Number [Percentage of Participants]	1.5 0.7%	1.0 0.5%

5. Secondary Outcome

Title	Percentage of Participant With Treatment Adherence Based on Tablet Count
Description	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).
Time Frame	Up to 48 Weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	TDF/FTC/RPV	TDF/FTC/EFV
Arm/Group Description	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.	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.
Measure Participants	207	206
Number [Percentage of Participants]	97.2 (1.981) 45.6%	97.6 (1.649) 46.3%

6. Secondary Outcome

Title	Number of Participants With Treatment-Emergent Nucleoside Reverse Transcriptase Inhibitor (N[t]RTI) or Nucleoside/Nucleotide Reverse Transcriptase Inhibitor (NNRTI) Mutations
Description	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.
Time Frame	Up to Week 48

Outcome Measure Data

Analysis Population Description

The intent-to-treat (ITT) population included all participants who were randomized and who had taken at least 1 dose of study drug.

Arm/Group Title	TDF/FTC/RPV	TDF/FTC/EFV
Arm/Group Description	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.	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.
Measure Participants	213	211
Number [Participants]	0 0%	0 0%

Adverse Events

Arm/Group Title	TDF/FTC/RPV		TDF/FTC/EFV
Arm/Group Description	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.		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.
All Cause Mortality
	TDF/FTC/RPV		TDF/FTC/EFV
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	TDF/FTC/RPV		TDF/FTC/EFV
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	16/213 (7.5%)		11/211 (5.2%)
Blood and lymphatic system disorders
Anaemia	0/213 (0%)		1/211 (0.5%)
Neutropenia	0/213 (0%)		1/211 (0.5%)
Cardiac disorders
Myocardial Infarction	1/213 (0.5%)		0/211 (0%)
Gastrointestinal disorders
Gastrointestinal Inflammation	0/213 (0%)		1/211 (0.5%)
Immune system disorders
Food Allergy	0/213 (0%)		1/211 (0.5%)
Infections and infestations
Appendicitis	1/213 (0.5%)		0/211 (0%)
Gastroenteritis	1/213 (0.5%)		0/211 (0%)
Influenza	1/213 (0.5%)		0/211 (0%)
Neurocysticercosis	1/213 (0.5%)		0/211 (0%)
Neurosyphilis	1/213 (0.5%)		0/211 (0%)
Pneumonia	1/213 (0.5%)		0/211 (0%)
Sinusitis	0/213 (0%)		1/211 (0.5%)
Injury, poisoning and procedural complications
Ankle Fracture	1/213 (0.5%)		0/211 (0%)
Investigations
Alanine Aminotransferase Increased	1/213 (0.5%)		0/211 (0%)
Metabolism and nutrition disorders
Diabetes Mellitus	3/213 (1.4%)		0/211 (0%)
Hyperglycaemia	2/213 (0.9%)		0/211 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer	0/213 (0%)		1/211 (0.5%)
Cervix Carcinoma	0/213 (0%)		1/211 (0.5%)
Uterine Leiomyoma	1/213 (0.5%)		0/211 (0%)
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous	2/213 (0.9%)		1/211 (0.5%)
Reproductive system and breast disorders
Adenomyosis	0/213 (0%)		1/211 (0.5%)
Endometriosis	0/213 (0%)		1/211 (0.5%)
Gynaecomastia	0/213 (0%)		1/211 (0.5%)
Uterine Haemorrhage	0/213 (0%)		1/211 (0.5%)
Other (Not Including Serious) Adverse Events
	TDF/FTC/RPV		TDF/FTC/EFV
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	128/213 (60.1%)		137/211 (64.9%)
Blood and lymphatic system disorders
Neutropenia	8/213 (3.8%)		12/211 (5.7%)
Ear and labyrinth disorders
Vertigo	11/213 (5.2%)		19/211 (9%)
Gastrointestinal disorders
Diarrhoea	8/213 (3.8%)		11/211 (5.2%)
Infections and infestations
Malaria	10/213 (4.7%)		22/211 (10.4%)
Upper Respiratory Tract Infection	63/213 (29.6%)		59/211 (28%)
Urinary Tract Infection	29/213 (13.6%)		28/211 (13.3%)
Investigations
Amylase Increased	14/213 (6.6%)		5/211 (2.4%)
Blood Pressure Increased	13/213 (6.1%)		9/211 (4.3%)
Metabolism and nutrition disorders
Increased Appetite	11/213 (5.2%)		3/211 (1.4%)
Musculoskeletal and connective tissue disorders
Arthralgia	17/213 (8%)		15/211 (7.1%)
Back Pain	20/213 (9.4%)		14/211 (6.6%)
Nervous system disorders
Dizziness	7/213 (3.3%)		14/211 (6.6%)
Headache	38/213 (17.8%)		29/211 (13.7%)
Somnolence	11/213 (5.2%)		3/211 (1.4%)
Respiratory, thoracic and mediastinal disorders
Cough	19/213 (8.9%)		7/211 (3.3%)
Skin and subcutaneous tissue disorders
Pruritus	14/213 (6.6%)		10/211 (4.7%)
Vascular disorders
Hypertension	5/213 (2.3%)		13/211 (6.2%)

Limitations/Caveats

It was an open label switch study with a significant number of patients (55%) on the Efavirenz (EFV) arm who did not switch their Nucleoside/Nucleotide Reverse Transcriptase Inhibitor (NNRTI) unlike in the Rilpivirine (RPV) arm where 100% switched.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.