Phase 3
Completed N=822
A Trial Comparing GSK1349572 50mg Once Daily to Raltegravir 400mg Twice Daily
Infection, Human Immunodeficiency Virus I
Source: ClinicalTrials.gov NCT01227824 ↗
Enrolled (actual)
822
Serious AEs
9.2%
Results posted
Jun 2014
Primary outcomePrimary: Percentage of Participants With Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) [HIV-1RNA] <50 Copies (c)/Milliliter (mL) Through Week 48 — 88; 85 Percentage of participants
Summary
The purpose of this trial is to assess the non-inferior antiviral activity of GSK1349572 50 mg once daily versus RAL 400mg twice daily over 48 weeks; non-inferiority will also be tested at Week 96. Both GSK1349572 and RAL will be given in combination with fixed-dose dual NRTI therapy (ABC/3TC or TDF/FTC). This study will be conducted in HIV-1 infected ART-naïve adult subjects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) [HIV-1RNA] <50 Copies (c)/Milliliter (mL) Through Week 48 |
88; 85 | — |
| SECONDARY Number of Participants With Detectable HIV-1 Virus That Has Genotypic or Phenotypic Evidence of INI Resistance. |
0; 1; 1; 2; 0; 1 | — |
| SECONDARY Number of Participants With Plasma HIV-1 RNA <50 c/mL |
332; 314 | — |
| SECONDARY Number of Participants With Plasma HIV-1 RNA <400 c/mL |
369; 356; 338; 321 | — |
| SECONDARY Change From Baseline in Plasma HIV-1 RNA Over Time |
4.538; 4.599; -2.817; -2.801; -2.897; -2.886 | — |
| SECONDARY Absolute Values in Plasma HIV-1 RNA Over Time |
4.538; 4.599; 1.718; 1.800; 1.646; 1.709 | — |
| SECONDARY Change From Baseline in Cluster of Differentiation (CD)4+ Cell Counts Over Time |
379.2; 374.3; 93.3; 97.2; 121.6; 126.6 | — |
| SECONDARY Absolute Values in CD4+ Cell Counts Over Time |
379.2; 374.3; 474.2; 471.8; 502.3; 502.4 | — |
| SECONDARY Number of Participants With the Indicated Post-Baseline HIV-associated Conditions and Progression, Excluding Recurrences |
10; 8; 3; 3; 6; 4 | — |
| SECONDARY Number of Participants With the Indicated Grade 1 to 4 Clinical Chemistry and Hematology Toxicities/Laboratory Adverse Events (AEs) |
57; 70; 7; 15; 67; 75 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From Time Zero to Time Tau [AUC(0-tau)] of DTG |
53.6 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) and Concentration at the End of a Dosing Interval (Ctau) of DTG |
3.69; 1.10 | — |
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
Exclusion Criteria
- Women who are pregnant or breastfeeding;
- Active Center for Disease and Prevention Control (CDC) Category C disease
- Moderate to severe hepatic impairment
- 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 (NCT01227824). 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.