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Study to Evaluate the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01095796
First received: March 17, 2010
Last updated: October 15, 2015
Last verified: October 2015
Results First Received: September 20, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: HIV
HIV Infections
Interventions: Drug: Stribild
Drug: Atripla
Drug: Stribild Placebo
Drug: Atripla Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled at sites in the United States and Puerto Rico. The first participant was screened on 16 March 2010. The last study visit occurred on 02 September 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
917 participants were screened.

Reporting Groups
  Description
Stribild Stribild® (elvitegravir (EVG) 150 mg/cobicistat (COBI) 150 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg) single-tablet regimen (STR) once daily plus placebo to match Atripla once daily prior to bedtime
Atripla Atripla® (efavirenz (EFV) 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily

Participant Flow:   Overall Study
    Stribild   Atripla
STARTED   353   354 
COMPLETED   58   65 
NOT COMPLETED   295   289 
Randomized but Not Treated                5                2 
Adverse Event                9                19 
Death                3                2 
Pregnancy                2                0 
Lack of Efficacy                5                3 
Investigator's Discretion                7                2 
Withdrew Consent                16                22 
Lost to Follow-up                27                29 
Participant Noncompliance                5                10 
Protocol Violation                1                0 
Participant Transferred to Another Study                215                200 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Analysis Set: participants were randomized and received at least one dose of study medication.

Reporting Groups
  Description
Stribild Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime
Atripla Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
Total Total of all reporting groups

Baseline Measures
   Stribild   Atripla   Total 
Overall Participants Analyzed 
[Units: Participants]
 348   352   700 
Age 
[Units: Years]
Mean (Standard Deviation)
 38  (10.4)   38  (10.6)   38  (10.5) 
Gender 
[Units: Participants]
     
Female   41   36   77 
Male   307   316   623 
Race/Ethnicity, Customized 
[Units: Participants]
     
American Indian or Alaska Native   2   4   6 
Asian   6   10   16 
Black or African Heritage   106   91   197 
Native Hawaiian or Pacific Islander   4   1   5 
White   214   227   441 
Other   16   19   35 
Region of Enrollment 
[Units: Participants]
     
United States   348   352   700 
HIV Disease Status 
[Units: Participants]
     
Asymptomatic   290   295   585 
Symptomatic HIV Infections   30   33   63 
AIDS   28   24   52 
Hepatitis B Virus (HBV) Infection Status 
[Units: Participants]
     
Negative   343   343   686 
Positive   5   9   14 
Hepatitis C Virus (HCV) Infection Status 
[Units: Participants]
     
Negative   331   337   668 
Positive   17   15   32 
HIV-1 RNA Category (copies/mL) 
[Units: Participants]
     
≤ 100,000   230   236   466 
> 100,000   118   116   234 
CD4 Cell Count (/µL) 
[Units: Participants]
     
≤ 50   7   6   13 
51 to ≤ 200   36   45   81 
201 to ≤ 350   112   96   208 
351 to ≤ 500   113   136   249 
> 500   80   69   149 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Percentage of Participants With Virologic Success Using the Food and Drug Administration (FDA)-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 Ribonucleic Acid (RNA) < 50 Copies/mL at Week 48   [ Time Frame: Week 48 ]

2.  Secondary:   The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 96   [ Time Frame: Week 96 ]

3.  Secondary:   The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 144   [ Time Frame: Week 144 ]

4.  Secondary:   The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 192   [ Time Frame: Week 192 ]

5.  Secondary:   The Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 48 Using the FDA-defined Time to Loss of Virologic Response (TLOVR) Algorithm   [ Time Frame: Week 48 ]

6.  Secondary:   The Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Weeks 48, 96, 144, and 192   [ Time Frame: Baseline; Weeks 48, 96, 144, and 192 ]

7.  Secondary:   The Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48   [ Time Frame: Week 48 ]


  Serious Adverse Events
  Hide Serious Adverse Events

Time Frame Up to 218 weeks plus 30 days
Additional Description Safety Analysis Set: participants were randomized and received at least one dose of study drug.

Reporting Groups
  Description
Stribild Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime
Atripla Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily

Serious Adverse Events
    Stribild   Atripla
Total, Serious Adverse Events     
# participants affected / at risk   69/348 (19.83%)   50/352 (14.20%) 
Blood and lymphatic system disorders     
Anaemia † 1     
# participants affected / at risk   0/348 (0.00%)   1/352 (0.28%) 
Antiphospholipid syndrome † 1     
# participants affected / at risk   0/348 (0.00%)   1/352 (0.28%) 
Splenic vein thrombosis † 1     
# participants affected / at risk   0/348 (0.00%)   1/352 (0.28%) 
Thrombocytopenia † 1     
# participants affected / at risk   0/348 (0.00%)   1/352 (0.28%) 
Cardiac disorders     
Acute myocardial infarction † 1     
# participants affected / at risk   0/348 (0.00%)   1/352 (0.28%) 
Bradycardia † 1     
# participants affected / at risk   0/348 (0.00%)   1/352 (0.28%) 
Intracardiac mass † 1     
# participants affected / at risk   0/348 (0.00%)   1/352 (0.28%) 
Palpitations † 1     
# participants affected / at risk   0/348 (0.00%)   1/352 (0.28%) 
Supraventricular tachycardia † 1     
# participants affected / at risk   0/348 (0.00%)   1/352 (0.28%) 
Tachycardia † 1     
# participants affected / at risk   0/348 (0.00%)   1/352 (0.28%) 
Gastrointestinal disorders     
Abdominal pain † 1     
# participants affected / at risk   1/348 (0.29%)   2/352 (0.57%) 
Colitis † 1     
# participants affected / at risk   2/348 (0.57%)   0/352 (0.00%) 
Diarrhoea † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Gastritis † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Haematemesis † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Inflammatory bowel disease † 1     
# participants affected / at risk   0/348 (0.00%)   1/352 (0.28%) 
Inguinal hernia † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Intestinal mass † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Intestinal perforation † 1     
# participants affected / at risk   1/348 (0.29%)   1/352 (0.28%) 
Mesenteric vein thrombosis † 1     
# participants affected / at risk   0/348 (0.00%)   1/352 (0.28%) 
Pancreatitis † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Pancreatitis acute † 1     
# participants affected / at risk   0/348 (0.00%)   1/352 (0.28%) 
Proctalgia † 1     
# participants affected / at risk   2/348 (0.57%)   0/352 (0.00%) 
Umbilical hernia † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Upper gastrointestinal haemorrhage † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Vomiting † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
General disorders     
Asthenia † 1     
# participants affected / at risk   0/348 (0.00%)   1/352 (0.28%) 
Chest pain † 1     
# participants affected / at risk   1/348 (0.29%)   1/352 (0.28%) 
Fatigue † 1     
# participants affected / at risk   2/348 (0.57%)   0/352 (0.00%) 
Non-cardiac chest pain † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Pyrexia † 1     
# participants affected / at risk   1/348 (0.29%)   2/352 (0.57%) 
Systemic inflammatory response syndrome † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Hepatobiliary disorders     
Cholecystitis † 1     
# participants affected / at risk   1/348 (0.29%)   1/352 (0.28%) 
Cholelithiasis † 1     
# participants affected / at risk   2/348 (0.57%)   0/352 (0.00%) 
Hepatitis alcoholic † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Liver injury † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Immune system disorders     
Anaphylactic reaction † 1     
# participants affected / at risk   0/348 (0.00%)   1/352 (0.28%) 
Infections and infestations     
Abscess limb † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Acute sinusitis † 1     
# participants affected / at risk   0/348 (0.00%)   1/352 (0.28%) 
Appendicitis † 1     
# participants affected / at risk   4/348 (1.15%)   3/352 (0.85%) 
Bronchitis † 1     
# participants affected / at risk   1/348 (0.29%)   3/352 (0.85%) 
Bronchitis bacterial † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Cellulitis † 1     
# participants affected / at risk   6/348 (1.72%)   0/352 (0.00%) 
Cellulitis staphylococcal † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Diarrhoea infectious † 1     
# participants affected / at risk   0/348 (0.00%)   1/352 (0.28%) 
Diverticulitis † 1     
# participants affected / at risk   1/348 (0.29%)   1/352 (0.28%) 
Gastroenteritis † 1     
# participants affected / at risk   2/348 (0.57%)   1/352 (0.28%) 
Giardiasis † 1     
# participants affected / at risk   0/348 (0.00%)   1/352 (0.28%) 
H1N1 influenza † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Herpes simplex † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Incision site infection † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Meningitis viral † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Muscle abscess † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Neurosyphilis † 1     
# participants affected / at risk   1/348 (0.29%)   2/352 (0.57%) 
Ovarian abscess † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Pelvic inflammatory disease † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Pneumonia † 1     
# participants affected / at risk   9/348 (2.59%)   2/352 (0.57%) 
Pneumonia legionella † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Pulmonary tuberculosis † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Pyelonephritis acute † 1     
# participants affected / at risk   0/348 (0.00%)   1/352 (0.28%) 
Rectal abscess † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Secondary syphilis † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Sepsis † 1     
# participants affected / at risk   0/348 (0.00%)   1/352 (0.28%) 
Sepsis syndrome † 1     
# participants affected / at risk   0/348 (0.00%)   1/352 (0.28%) 
Skin bacterial infection † 1     
# participants affected / at risk   0/348 (0.00%)   1/352 (0.28%) 
Subcutaneous abscess † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Urinary tract infection † 1     
# participants affected / at risk   0/348 (0.00%)   1/352 (0.28%) 
Viral infection † 1     
# participants affected / at risk   3/348 (0.86%)   0/352 (0.00%) 
Injury, poisoning and procedural complications     
Ankle fracture † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Cervical vertebral fracture † 1     
# participants affected / at risk   0/348 (0.00%)   1/352 (0.28%) 
Facial bones fracture † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Femur fracture † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Fibula fracture † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Gun shot wound † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Head injury † 1     
# participants affected / at risk   0/348 (0.00%)   1/352 (0.28%) 
Humerus fracture † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Intentional overdose † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Joint dislocation † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Limb injury † 1     
# participants affected / at risk   0/348 (0.00%)   1/352 (0.28%) 
Lumbar vertebral fracture † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Post procedural haemorrhage † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Subdural haematoma † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Tibia fracture † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Investigations     
Alanine aminotransferase increased † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Aspartate aminotransferase increased † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Transaminases increased † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Metabolism and nutrition disorders     
Dehydration † 1     
# participants affected / at risk   0/348 (0.00%)   2/352 (0.57%) 
Diabetic ketoacidosis † 1     
# participants affected / at risk   0/348 (0.00%)   1/352 (0.28%) 
Musculoskeletal and connective tissue disorders     
Arthritis † 1     
# participants affected / at risk   0/348 (0.00%)   1/352 (0.28%) 
Back pain † 1     
# participants affected / at risk   0/348 (0.00%)   1/352 (0.28%) 
Intervertebral disc protrusion † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Synovitis † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma † 1     
# participants affected / at risk   0/348 (0.00%)   1/352 (0.28%) 
Anal cancer † 1     
# participants affected / at risk   0/348 (0.00%)   1/352 (0.28%) 
Anal cancer recurrent † 1     
# participants affected / at risk   0/348 (0.00%)   1/352 (0.28%) 
Anorectal human papilloma virus infection † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Bladder cancer recurrent † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Burkitt's lymphoma † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Colorectal cancer stage IV † 1     
# participants affected / at risk   0/348 (0.00%)   1/352 (0.28%) 
Diffuse large B-cell lymphoma † 1     
# participants affected / at risk   0/348 (0.00%)   1/352 (0.28%) 
Hodgkin's disease † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Immune reconstitution inflammatory syndrome associated Kaposi's sarcoma † 1     
# participants affected / at risk   0/348 (0.00%)   1/352 (0.28%) 
Kaposi's sarcoma † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Lymphoma † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Malignant melanoma † 1     
# participants affected / at risk   0/348 (0.00%)   1/352 (0.28%) 
Metastatic neoplasm † 1     
# participants affected / at risk   0/348 (0.00%)   1/352 (0.28%) 
Uterine leiomyoma † 1     
# participants affected / at risk   2/348 (0.57%)   1/352 (0.28%) 
Nervous system disorders     
Convulsion † 1     
# participants affected / at risk   0/348 (0.00%)   1/352 (0.28%) 
Grand mal convulsion † 1     
# participants affected / at risk   0/348 (0.00%)   1/352 (0.28%) 
Headache † 1     
# participants affected / at risk   1/348 (0.29%)   1/352 (0.28%) 
Hepatic encephalopathy † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Migraine † 1     
# participants affected / at risk   1/348 (0.29%)   1/352 (0.28%) 
Presyncope † 1     
# participants affected / at risk   0/348 (0.00%)   1/352 (0.28%) 
Syncope † 1     
# participants affected / at risk   1/348 (0.29%)   2/352 (0.57%) 
Psychiatric disorders     
Alcoholism † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Bipolar disorder † 1     
# participants affected / at risk   1/348 (0.29%)   1/352 (0.28%) 
Completed suicide † 1     
# participants affected / at risk   1/348 (0.29%)   2/352 (0.57%) 
Depression † 1     
# participants affected / at risk   2/348 (0.57%)   1/352 (0.28%) 
Depression suicidal † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Drug dependence † 1     
# participants affected / at risk   0/348 (0.00%)   1/352 (0.28%) 
Major depression † 1     
# participants affected / at risk   0/348 (0.00%)   1/352 (0.28%) 
Psychotic disorder † 1     
# participants affected / at risk   0/348 (0.00%)   1/352 (0.28%) 
Suicidal behaviour † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Suicidal ideation † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Suicide attempt † 1     
# participants affected / at risk   1/348 (0.29%)   2/352 (0.57%) 
Renal and urinary disorders     
Nephrolithiasis † 1     
# participants affected / at risk   0/348 (0.00%)   2/352 (0.57%) 
Renal failure † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Renal failure acute † 1     
# participants affected / at risk   0/348 (0.00%)   1/352 (0.28%) 
Reproductive system and breast disorders     
Pelvic pain † 1     
# participants affected / at risk   0/348 (0.00%)   1/352 (0.28%) 
Testicular mass † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma † 1     
# participants affected / at risk   3/348 (0.86%)   1/352 (0.28%) 
Chronic obstructive pulmonary disease † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Dyspnoea † 1     
# participants affected / at risk   0/348 (0.00%)   2/352 (0.57%) 
Dyspnoea exertional † 1     
# participants affected / at risk   0/348 (0.00%)   1/352 (0.28%) 
Pleural effusion † 1     
# participants affected / at risk   0/348 (0.00%)   1/352 (0.28%) 
Pneumomediastinum † 1     
# participants affected / at risk   0/348 (0.00%)   1/352 (0.28%) 
Pulmonary embolism † 1     
# participants affected / at risk   0/348 (0.00%)   1/352 (0.28%) 
Pulmonary thrombosis † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Respiratory failure † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash maculo-papular † 1     
# participants affected / at risk   0/348 (0.00%)   1/352 (0.28%) 
Social circumstances     
Alcohol use † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Vascular disorders     
Deep vein thrombosis † 1     
# participants affected / at risk   2/348 (0.57%)   0/352 (0.00%) 
Haematoma † 1     
# participants affected / at risk   0/348 (0.00%)   1/352 (0.28%) 
Hypertension † 1     
# participants affected / at risk   2/348 (0.57%)   0/352 (0.00%) 
Hypertensive crisis † 1     
# participants affected / at risk   1/348 (0.29%)   0/352 (0.00%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 17.0




  Other Adverse Events


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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
There were no limitations affecting the analysis or results.


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