Phase 3
Completed N=833
A Trial Comparing GSK1349572 50mg Plus Abacavir/Lamivudine Once Daily to Atripla (Also Called The SINGLE Trial)
Infection, Human Immunodeficiency Virus I
Source: ClinicalTrials.gov NCT01263015 ↗
Enrolled (actual)
833
Serious AEs
15.0%
Results posted
Jul 2014
Primary outcomePrimary: Proportion of Subjects Responding Based on Plasma HIV-1 RNA <50 c/mL at Week 48 — 88; 81 Percentage of participants — p=0.003
Summary
The purpose of this trial is to assess the non-inferior antiviral activity of GSK1349572 50 mg plus Abacavir/Lamivudine once daily versus Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate (ATRIPLA® a trade mark of Bristol-Myers Squibb and Gilead Sciences LLC) over 48 weeks; non-inferiority will also be tested at Week 96. This study will be conducted in HIV-1 infected ART-naïve adult subjects. Long term antiviral activity, tolerability, safety, and development of viral resistance will be evaluated.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Subjects Responding Based on Plasma HIV-1 RNA <50 c/mL at Week 48 |
88; 81 | 0.003 sig |
| SECONDARY Time to Viral Suppression (<50 c/mL) |
28; 84 | — |
| SECONDARY Percentage of Participants With Plasma Human Immunodeficiency Virus -1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 96 and Week 144 |
77; 70; 71; 63 | 0.016 sig |
| SECONDARY Number of Participants With a Confirmed Plasma HIV-1 RNA Level >=1000 c/mL at or After Week 16 and Before Week 24, or a Confirmed Plasma HIV-1 RNA Level >=200 c/mL at or After Week 24 |
11; 8; 403; 411 | — |
| SECONDARY Change From Baseline in Plasma HIV-1 RNA at Weeks 2, 4, 8, 12, 16, 24, 32, 40,48, 60, 72, 84, 96, 108, 120, 132 and 144 |
-2.46; -1.96; -2.88; -2.25; -2.99; -2.60 | — |
| SECONDARY Change From Baseline in CD4+ Cell Counts at Week 144 |
378.48; 331.57 | 0.003 sig |
| SECONDARY Change From Baseline in CD4+ Cell Counts at Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144 |
117.6; 80.9; 164.6; 124.4; 187.5; 153.0 | — |
| SECONDARY Number of Participants With the Indicated Post-baseline HIV-associated Conditions and Progression, Excluding Recurrences at Week 144 |
17; 24; 12; 17; 5; 6 | — |
| SECONDARY Number of Participants With the Indicated Grade 1 to 4 Clinical and Hematology Toxicities at Week144 |
62; 81; 0; 1; 17; 53 | — |
| SECONDARY Number of Participants With the Indicated Genotypic Resistance With Virological Failure (VF) Through 144 |
0; 1; 0; 1; 0; 2 | — |
| SECONDARY Change From Baseline in the Symptom Bother Score (SBS) at Week 4 Through Week 48 |
-1.818; -1.246 | — |
Eligibility Criteria
Inclusion Criteria
- Screening plasma HIV-1 RNA ≥1000 c/mL
- Antiretroviral-naïve (≤ 10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection)
- Ability to understand and sign a written informed consent form
- Willingness to use approved methods of contraception to avoid pregnancy (women of child bearing potential only)
- Age equal to or greater than 18 years
- A negative HLAB*5701 allele assessment
Exclusion Criteria
- Women who are pregnant or breastfeeding;
- Active Center for Disease and Prevention Control (CDC) Category C disease
- Hepatic impairment
- HBV co-infection
- Anticipated need for HCV therapy during the study
- Allergy or intolerance to the study drugs or their components or drugs of their class
- Malignancy within the past 5 years
- Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening
- Treatment with radiation therapy, cytotoxic chemotherapeutic agents or any immunomodulator within 28 days of Screening
- Exposure to an agent with documented activity against HIV-1 in vitro or an experimental vaccine or drug within 28 days of first dose of study medication
- Primary viral resistance in the Screening result
- Verified Grade 4 laboratory abnormality
- ALT >5 xULN
- ALT ≥ 3xULN and bilirubin ≥ 1.5xULN (with >35% direct bilirubin);
- Estimated creatinine clearance <50 mL/min
- Recent history (≤3 months) of upper or lower gastrointestinal bleed
Data sourced from ClinicalTrials.gov (NCT01263015). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.