A Dose Ranging Trial of GSK1349572 and 2 NRTI in HIV-1 Infected, Therapy Naive Subjects (ING112276)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Shionogi
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00951015
First received: July 30, 2009
Last updated: December 19, 2013
Last verified: October 2013
Results First Received: August 22, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Infection, Human Immunodeficiency Virus
Interventions: Drug: GSK1349572
Drug: efavirenz

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible participants (par.) were randomized (ran) to receive Dolutegravir (DTG) (3 dose groups) or Efavirenz for 96 weeks. At Week 96, par. ran. to any dose of DTG entered an open-label phase and continued to receive DTG at the selected dose of 50 milligrams. A total of 208 par. were ran., and 205 received at least one dose of study medication.

Reporting Groups
  Description
DTG 10 mg OD Participants received Dolutegravir (DTG) 10 milligrams (mg), DTG matching placebo, and Abacavir (ABC)/Lamivudine (3TC) 600 mg/300 mg or Tenofovir (TDF)/Emtricitabine (FTC) 300 mg/200 mg orally once daily (OD) for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 25 mg OD Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 50 mg OD Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
EFV 600 mg OD Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.

Participant Flow:   Overall Study
    DTG 10 mg OD     DTG 25 mg OD     DTG 50 mg OD     EFV 600 mg OD  
STARTED     53     51     51     50  
Ongoing     47     45     46     8  
COMPLETED     0     0     0     32  
NOT COMPLETED     53     51     51     18  
Adverse Event                 1                 1                 2                 5  
Lack of Efficacy                 1                 1                 0                 0  
Protocol Violation                 1                 1                 1                 0  
Protocol-Defined Stopping Criteria                 0                 0                 0                 1  
Lost to Follow-up                 0                 2                 1                 2  
Withdrawal by Subject                 3                 1                 1                 2  
Ongoing                 47                 45                 46                 8  



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
DTG 10 mg OD Participants received Dolutegravir (DTG) 10 milligrams (mg), DTG matching placebo, and Abacavir (ABC)/Lamivudine (3TC) 600 mg/300 mg or Tenofovir (TDF)/Emtricitabine (FTC) 300 mg/200 mg orally once daily (OD) for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 25 mg OD Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 50 mg OD Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
EFV 600 mg OD Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
Total Total of all reporting groups

Baseline Measures
    DTG 10 mg OD     DTG 25 mg OD     DTG 50 mg OD     EFV 600 mg OD     Total  
Number of Participants  
[units: participants]
  53     51     51     50     205  
Age  
[units: Years]
Mean ± Standard Deviation
  34.2  ± 9.25     37.0  ± 9.79     37.0  ± 8.89     40.7  ± 11.19     37.2  ± 10.00  
Gender  
[units: Participants]
         
Female     11     5     6     6     28  
Male     42     46     45     44     177  
Race/Ethnicity, Customized  
[units: participants]
         
African American/African Heritage (HER)     7     6     8     4     25  
American Indian or Alaska Native     1     3     4     2     10  
Japanese/East Asian HER/South East Asian HER     0     0     0     1     1  
Native Hawaiian or other Pacific Islander     3     0     0     0     3  
White     41     42     38     43     164  
African American/African HER & White     0     0     1     0     1  
Asian & White     1     0     0     0     1  



  Outcome Measures
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1.  Primary:   Number of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 16   [ Time Frame: Week 16 ]

2.  Secondary:   Viral Change Over the Initial 2 Weeks of Treatment   [ Time Frame: Baseline and Week 2 ]

3.  Secondary:   Change From Baseline in HIV-1 RNA at the Indicated Time Points   [ Time Frame: Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96 ]

4.  Secondary:   Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at the Indicated Time Points   [ Time Frame: Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96 ]

5.  Secondary:   Number of Participants With New HIV-associated Conditions of the Indicated Class   [ Time Frame: From Baseline up to Week 96 ]

6.  Secondary:   Number of Participants With the Indicated Type of HIV-1 Disease Progression (AIDS or Death)   [ Time Frame: From Baseline up to Week 96 ]

7.  Secondary:   Number of Participants With Plasma HIV-1 RNA <50 c/mL   [ Time Frame: Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96 ]

8.  Secondary:   Number of Participants With Plasma HIV-1 RNA <400 c/mL   [ Time Frame: Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96 ]

9.  Secondary:   Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Events (SAE)   [ Time Frame: From Baseline up to Week 96/Early Withdrawal ]

10.  Secondary:   Number of Participants With the Indicated Grade 1 to Grade 4 Treatment-emergent Clinical Chemistry and Hematology Toxicities   [ Time Frame: From Baseline up to Week 96/Early Withdrawal ]

11.  Secondary:   Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance   [ Time Frame: From Baseline up to Week 96/Early Withdrawal ]

12.  Secondary:   Number of Participants With the Indicated Treatment-emergent Major Mutations of Other Classes Detected at the Time of Protocol-defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance   [ Time Frame: From Baseline up to Week 96/Early Withdrawal ]

13.  Secondary:   Number of Participants With the Indicated Fold Increase in DTG FC (Fold Change in IC50 Relative to Wild-type Virus) at the Time of PDVF, as a Measure of Post-Baseline Phenotypic Resistance   [ Time Frame: From Baseline up to Week 96/Early Withdrawal ]

14.  Secondary:   Plasma DTG Concentration   [ Time Frame: Week 2, Week 12, and Week 24 ]

15.  Secondary:   AUC(0-tau) of DTG   [ Time Frame: pre-dose and 2, 3, 4, 8, and 24 hours post-dose at Week 2 ]

16.  Secondary:   Cmax, Cmin, and Ctau of DTG   [ Time Frame: pre-dose and 2, 3, 4, 8, and 24 hours post-dose at Week 2 ]

17.  Secondary:   C0 and C0 Avg of DTG   [ Time Frame: Week 2, Week 12, and Week 24 ]

18.  Secondary:   Time to Maximal Drug Concentration (Tmax) of DTG   [ Time Frame: pre-dose and 2, 3, 4, 8, and 24 hours post-dose at Week 2 ]

19.  Secondary:   Relationship Between the Change From Baseline in Plasma HIV-1 RNA at Week 2 and the Indicated Plasma DTG PK Parameters   [ Time Frame: Week 2 ]

20.  Secondary:   Relationship Between the Change From Baseline in CD4+ Cell Counts at Week 96 and the Indicated Plasma DTG PK Parameters   [ Time Frame: Week 96 ]

21.  Secondary:   Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters   [ Time Frame: Week 96 ]

22.  Secondary:   Relationship Between Gastrointestinal System Organ Class AEs of Special Interest at Week 96 and the Indicated Plasma DTG PK Parameters   [ Time Frame: Week 96 ]

23.  Other Pre-specified:   Change From Baseline in Cluster of Differentiation 8+ (CD8+) Cell Counts at the Indicated Time Points   [ Time Frame: Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96 ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to Week 96/Early Withdrawal.
Additional Description SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.

Frequency Threshold
Threshold above which other adverse events are reported   3%  

Reporting Groups
  Description
DTG 10 mg OD Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 25 mg OD Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 50 mg OD Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
EFV 600 mg OD Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.

Other Adverse Events
    DTG 10 mg OD     DTG 25 mg OD     DTG 50 mg OD     EFV 600 mg OD  
Total, other (not including serious) adverse events          
# participants affected / at risk     45/53     40/51     43/51     41/50  
Blood and lymphatic system disorders          
Lymphadenopathy † 1        
# participants affected / at risk     2/53 (3.77%)     3/51 (5.88%)     0/51 (0.00%)     0/50 (0.00%)  
Ear and labyrinth disorders          
Vertigo † 1        
# participants affected / at risk     2/53 (3.77%)     1/51 (1.96%)     2/51 (3.92%)     2/50 (4.00%)  
Ear pain † 1        
# participants affected / at risk     0/53 (0.00%)     2/51 (3.92%)     0/51 (0.00%)     1/50 (2.00%)  
Endocrine disorders          
Hypogonadism † 1        
# participants affected / at risk     2/53 (3.77%)     0/51 (0.00%)     1/51 (1.96%)     0/50 (0.00%)  
Eye disorders          
Conjunctivitis † 1        
# participants affected / at risk     0/53 (0.00%)     2/51 (3.92%)     2/51 (3.92%)     0/50 (0.00%)  
Gastrointestinal disorders          
Diarrhoea † 1        
# participants affected / at risk     7/53 (13.21%)     9/51 (17.65%)     9/51 (17.65%)     7/50 (14.00%)  
Nausea † 1        
# participants affected / at risk     10/53 (18.87%)     7/51 (13.73%)     6/51 (11.76%)     6/50 (12.00%)  
Abdominal pain upper † 1        
# participants affected / at risk     4/53 (7.55%)     3/51 (5.88%)     1/51 (1.96%)     1/50 (2.00%)  
Abdominal pain † 1        
# participants affected / at risk     3/53 (5.66%)     1/51 (1.96%)     2/51 (3.92%)     1/50 (2.00%)  
Vomiting † 1        
# participants affected / at risk     3/53 (5.66%)     3/51 (5.88%)     0/51 (0.00%)     1/50 (2.00%)  
Dyspepsia † 1        
# participants affected / at risk     0/53 (0.00%)     2/51 (3.92%)     2/51 (3.92%)     2/50 (4.00%)  
Abdominal discomfort † 1        
# participants affected / at risk     2/53 (3.77%)     1/51 (1.96%)     1/51 (1.96%)     1/50 (2.00%)  
Toothache † 1        
# participants affected / at risk     2/53 (3.77%)     1/51 (1.96%)     1/51 (1.96%)     1/50 (2.00%)  
Constipation † 1        
# participants affected / at risk     3/53 (5.66%)     1/51 (1.96%)     0/51 (0.00%)     0/50 (0.00%)  
Haemorrhoids † 1        
# participants affected / at risk     0/53 (0.00%)     0/51 (0.00%)     2/51 (3.92%)     2/50 (4.00%)  
General disorders          
Fatigue † 1        
# participants affected / at risk     3/53 (5.66%)     3/51 (5.88%)     2/51 (3.92%)     6/50 (12.00%)  
Pyrexia † 1        
# participants affected / at risk     5/53 (9.43%)     4/51 (7.84%)     1/51 (1.96%)     4/50 (8.00%)  
Asthenia † 1        
# participants affected / at risk     4/53 (7.55%)     3/51 (5.88%)     1/51 (1.96%)     0/50 (0.00%)  
Chest pain † 1        
# participants affected / at risk     1/53 (1.89%)     1/51 (1.96%)     0/51 (0.00%)     2/50 (4.00%)  
Influenza like illness † 1        
# participants affected / at risk     1/53 (1.89%)     0/51 (0.00%)     2/51 (3.92%)     1/50 (2.00%)  
Immune system disorders          
Seasonal allergy † 1        
# participants affected / at risk     1/53 (1.89%)     2/51 (3.92%)     1/51 (1.96%)     0/50 (0.00%)  
Infections and infestations          
Nasopharyngitis † 1        
# participants affected / at risk     8/53 (15.09%)     8/51 (15.69%)     6/51 (11.76%)     5/50 (10.00%)  
Influenza † 1        
# participants affected / at risk     5/53 (9.43%)     5/51 (9.80%)     4/51 (7.84%)     3/50 (6.00%)  
Bronchitis † 1        
# participants affected / at risk     5/53 (9.43%)     2/51 (3.92%)     2/51 (3.92%)     5/50 (10.00%)  
Upper respiratory tract infection † 1        
# participants affected / at risk     2/53 (3.77%)     3/51 (5.88%)     6/51 (11.76%)     1/50 (2.00%)  
Sinusitis † 1        
# participants affected / at risk     2/53 (3.77%)     2/51 (3.92%)     3/51 (5.88%)     4/50 (8.00%)  
Respiratory tract infection † 1        
# participants affected / at risk     4/53 (7.55%)     1/51 (1.96%)     2/51 (3.92%)     3/50 (6.00%)  
Pharyngitis † 1        
# participants affected / at risk     3/53 (5.66%)     3/51 (5.88%)     1/51 (1.96%)     2/50 (4.00%)  
Syphilis † 1        
# participants affected / at risk     1/53 (1.89%)     3/51 (5.88%)     1/51 (1.96%)     4/50 (8.00%)  
Oral herpes † 1        
# participants affected / at risk     4/53 (7.55%)     2/51 (3.92%)     0/51 (0.00%)     0/50 (0.00%)  
Respiratory tract infection viral † 1        
# participants affected / at risk     3/53 (5.66%)     1/51 (1.96%)     0/51 (0.00%)     1/50 (2.00%)  
Tinea pedis † 1        
# participants affected / at risk     2/53 (3.77%)     1/51 (1.96%)     1/51 (1.96%)     1/50 (2.00%)  
Tonsillitis † 1        
# participants affected / at risk     3/53 (5.66%)     1/51 (1.96%)     0/51 (0.00%)     1/50 (2.00%)  
Viral infection † 1        
# participants affected / at risk     1/53 (1.89%)     3/51 (5.88%)     0/51 (0.00%)     1/50 (2.00%)  
Cellulitis † 1        
# participants affected / at risk     0/53 (0.00%)     1/51 (1.96%)     1/51 (1.96%)     2/50 (4.00%)  
Tooth abscess † 1        
# participants affected / at risk     2/53 (3.77%)     1/51 (1.96%)     1/51 (1.96%)     0/50 (0.00%)  
Anogenital warts † 1        
# participants affected / at risk     2/53 (3.77%)     0/51 (0.00%)     1/51 (1.96%)     0/50 (0.00%)  
Furuncle † 1        
# participants affected / at risk     1/53 (1.89%)     0/51 (0.00%)     2/51 (3.92%)     0/50 (0.00%)  
Gonorrhoea † 1        
# participants affected / at risk     0/53 (0.00%)     1/51 (1.96%)     0/51 (0.00%)     2/50 (4.00%)  
Otitis media † 1        
# participants affected / at risk     3/53 (5.66%)     0/51 (0.00%)     0/51 (0.00%)     0/50 (0.00%)  
Tooth infection † 1        
# participants affected / at risk     0/53 (0.00%)     2/51 (3.92%)     1/51 (1.96%)     0/50 (0.00%)  
Urinary tract infection † 1        
# participants affected / at risk     1/53 (1.89%)     0/51 (0.00%)     2/51 (3.92%)     0/50 (0.00%)  
Genital herpes † 1        
# participants affected / at risk     0/53 (0.00%)     0/51 (0.00%)     2/51 (3.92%)     0/50 (0.00%)  
Molluscum contagiosum † 1        
# participants affected / at risk     0/53 (0.00%)     0/51 (0.00%)     2/51 (3.92%)     0/50 (0.00%)  
Injury, poisoning and procedural complications          
Contusion † 1        
# participants affected / at risk     2/53 (3.77%)     0/51 (0.00%)     0/51 (0.00%)     0/50 (0.00%)  
Laceration † 1        
# participants affected / at risk     0/53 (0.00%)     2/51 (3.92%)     0/51 (0.00%)     0/50 (0.00%)  
Investigations          
Blood creatine phosphokinase increased † 1        
# participants affected / at risk     0/53 (0.00%)     3/51 (5.88%)     0/51 (0.00%)     0/50 (0.00%)  
Metabolism and nutrition disorders          
Hyperglycaemia † 1        
# participants affected / at risk     2/53 (3.77%)     0/51 (0.00%)     1/51 (1.96%)     0/50 (0.00%)  
Hypercholesterolaemia † 1        
# participants affected / at risk     0/53 (0.00%)     2/51 (3.92%)     0/51 (0.00%)     0/50 (0.00%)  
Musculoskeletal and connective tissue disorders          
Back pain † 1        
# participants affected / at risk     3/53 (5.66%)     3/51 (5.88%)     2/51 (3.92%)     4/50 (8.00%)  
Arthralgia † 1        
# participants affected / at risk     1/53 (1.89%)     3/51 (5.88%)     2/51 (3.92%)     1/50 (2.00%)  
Musculoskeletal pain † 1        
# participants affected / at risk     1/53 (1.89%)     2/51 (3.92%)     3/51 (5.88%)     0/50 (0.00%)  
Myalgia † 1        
# participants affected / at risk     2/53 (3.77%)     0/51 (0.00%)     2/51 (3.92%)     1/50 (2.00%)  
Muscle spasms † 1        
# participants affected / at risk     0/53 (0.00%)     4/51 (7.84%)     0/51 (0.00%)     0/50 (0.00%)  
Exostosis † 1        
# participants affected / at risk     1/53 (1.89%)     0/51 (0.00%)     2/51 (3.92%)     0/50 (0.00%)  
Pain in extremity † 1        
# participants affected / at risk     0/53 (0.00%)     2/51 (3.92%)     1/51 (1.96%)     0/50 (0.00%)  
Nervous system disorders          
Headache † 1        
# participants affected / at risk     7/53 (13.21%)     6/51 (11.76%)     9/51 (17.65%)     3/50 (6.00%)  
Dizziness † 1        
# participants affected / at risk     2/53 (3.77%)     3/51 (5.88%)     3/51 (5.88%)     11/50 (22.00%)  
Somnolence † 1        
# participants affected / at risk     2/53 (3.77%)     1/51 (1.96%)     1/51 (1.96%)     2/50 (4.00%)  
Paraesthesia † 1        
# participants affected / at risk     2/53 (3.77%)     0/51 (0.00%)     0/51 (0.00%)     2/50 (4.00%)  
Dysgeusia † 1        
# participants affected / at risk     2/53 (3.77%)     1/51 (1.96%)     0/51 (0.00%)     0/50 (0.00%)  
Restless legs syndrome † 1        
# participants affected / at risk     0/53 (0.00%)     0/51 (0.00%)     0/51 (0.00%)     2/50 (4.00%)  
Psychiatric disorders          
Insomnia † 1        
# participants affected / at risk     0/53 (0.00%)     7/51 (13.73%)     6/51 (11.76%)     6/50 (12.00%)  
Depression † 1        
# participants affected / at risk     3/53 (5.66%)     6/51 (11.76%)     2/51 (3.92%)     5/50 (10.00%)  
Anxiety † 1        
# participants affected / at risk     1/53 (1.89%)     2/51 (3.92%)     2/51 (3.92%)     3/50 (6.00%)  
Abnormal dreams † 1        
# participants affected / at risk     1/53 (1.89%)     2/51 (3.92%)     0/51 (0.00%)     4/50 (8.00%)  
Nightmare † 1        
# participants affected / at risk     0/53 (0.00%)     0/51 (0.00%)     0/51 (0.00%)     3/50 (6.00%)  
Stress † 1        
# participants affected / at risk     0/53 (0.00%)     1/51 (1.96%)     2/51 (3.92%)     0/50 (0.00%)  
Renal and urinary disorders          
Nephrolithiasis † 1        
# participants affected / at risk     2/53 (3.77%)     1/51 (1.96%)     1/51 (1.96%)     1/50 (2.00%)  
Proteinuria † 1        
# participants affected / at risk     0/53 (0.00%)     2/51 (3.92%)     1/51 (1.96%)     0/50 (0.00%)  
Reproductive system and breast disorders          
Erectile dysfunction † 1        
# participants affected / at risk     1/53 (1.89%)     0/51 (0.00%)     2/51 (3.92%)     1/50 (2.00%)  
Respiratory, thoracic and mediastinal disorders          
Cough † 1        
# participants affected / at risk     5/53 (9.43%)     4/51 (7.84%)     6/51 (11.76%)     2/50 (4.00%)  
Oropharyngeal pain † 1        
# participants affected / at risk     3/53 (5.66%)     0/51 (0.00%)     3/51 (5.88%)     1/50 (2.00%)  
Sinus congestion † 1        
# participants affected / at risk     0/53 (0.00%)     1/51 (1.96%)     2/51 (3.92%)     2/50 (4.00%)  
Asthma † 1        
# participants affected / at risk     1/53 (1.89%)     2/51 (3.92%)     1/51 (1.96%)     0/50 (0.00%)  
Dyspnoea † 1        
# participants affected / at risk     0/53 (0.00%)     2/51 (3.92%)     1/51 (1.96%)     0/50 (0.00%)  
Respiratory tract congestion † 1        
# participants affected / at risk     0/53 (0.00%)     0/51 (0.00%)     2/51 (3.92%)     0/50 (0.00%)  
Rhinorrhoea † 1        
# participants affected / at risk     0/53 (0.00%)     0/51 (0.00%)     2/51 (3.92%)     0/50 (0.00%)  
Skin and subcutaneous tissue disorders          
Rash † 1        
# participants affected / at risk     5/53 (9.43%)     3/51 (5.88%)     3/51 (5.88%)     6/50 (12.00%)  
Pruritus † 1        
# participants affected / at risk     2/53 (3.77%)     0/51 (0.00%)     1/51 (1.96%)     3/50 (6.00%)  
Dermatitis † 1        
# participants affected / at risk     0/53 (0.00%)     2/51 (3.92%)     1/51 (1.96%)     1/50 (2.00%)  
Night sweats † 1        
# participants affected / at risk     1/53 (1.89%)     1/51 (1.96%)     2/51 (3.92%)     0/50 (0.00%)  
Photosensitivity reaction † 1        
# participants affected / at risk     0/53 (0.00%)     0/51 (0.00%)     2/51 (3.92%)     1/50 (2.00%)  
Vascular disorders          
Hypertension † 1        
# participants affected / at risk     0/53 (0.00%)     1/51 (1.96%)     0/51 (0.00%)     2/50 (4.00%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA



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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
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
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Results Point of Contact:  
Name/Title: GSK Response Center
Organization: ViiV Healthcare
phone: 866-435-7343


No publications provided by ViiV Healthcare

Publications automatically indexed to this study:

Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT00951015     History of Changes
Other Study ID Numbers: 112276
Study First Received: July 30, 2009
Results First Received: August 22, 2013
Last Updated: December 19, 2013
Health Authority: Spain: Agencia Española del Medicamento y Productos Sanitarios
Russia: Russian Ministry of Health
Germany: Bundesinstitut für Arzneimittel und Medizinprodukte
France: Agence Française de Sécurité Sanitaire des Produits de Santé
United States: Food and Drug Administration