Phase 3
Completed N=753
A Study To Assess GW433908 (Fosamprenavir) Containing Regimens In HIV-1 Infected Subjects
Infection, Human Immunodeficiency Virus
Source: ClinicalTrials.gov NCT00296504 ↗
Enrolled (actual)
753
Serious AEs
19.9%
Results posted
Nov 2011
Primary outcomePrimary: Number of Participants With Any Adverse Event (AE): Interim Analysis — 117; 16; 215; 52 participants
Summary
GW433908 (fosamprenavir; FPV)is a pro-drug of amprenavir (APV) which is more water soluble and can be formulated into a tablet with a reduced pill burden (four 700mg tablets of FPV versus sixteen 150mg capsules daily for APV. This study is designed to provide additional information on long term safety and tolerability of FPV containing regimens for those subjects who received FPV in previous GlaxoSmithKline studies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Any Adverse Event (AE): Interim Analysis |
117; 16; 215; 52; 72; 75 | — |
| PRIMARY Number of Participants With Any Adverse Event (AE): Final Analysis |
95 | — |
| PRIMARY Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 |
10; -41; 51; 20; 9; 14 | — |
| PRIMARY Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432 |
237; 248; 137; 120; 132; 202 | — |
| PRIMARY Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 120, 180, 204, and 216 |
0.1; -0.4; 0.4; 0.1; -0.2; -0.6 | — |
| PRIMARY Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 96, 132, and 168 |
-0.4; -0.3; -0.1; -0.8; -0.5; 0.1 | — |
| PRIMARY Median Value of the Total Cholesterol/HDL Ratio at Weeks 120, 180, 204, 216, and 432 |
5.5; 5.5; 3.7; 3.5; 4.0 | — |
| PRIMARY Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 |
-7; -2; -7; 0; -8; 0 | — |
| PRIMARY Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168 |
-6; -5; 1; 0; -6; -4 | — |
| PRIMARY Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432 |
18; 21; 20; 21; 21; 18 | — |
| SECONDARY Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) |
1; 0; 61; 92; 94; 85 | — |
| SECONDARY Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) |
0; 1; 84; 59; 75; 82 | — |
| SECONDARY Percentage of Participants With Plasma HIV-1RNA <50 Copies Per Milliliter at Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432 (Observed) |
93; 86; 87; 93; 89; 92 | — |
| SECONDARY Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis |
211; 505; 167; 297; 426; 499 | — |
| SECONDARY Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis |
311; 304; 477; 361; 367; 348 | — |
| SECONDARY Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216 |
4.82; 1.69; 4.82; 1.78; 1.69; 1.69 | — |
| SECONDARY Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168 |
3.96; 4.06; 1.7; 1.81; 1.7; 1.81 | — |
| SECONDARY Median Plasma HIV-1 RNA at Weeks 180, 240, 300, 360, 420, and 432 |
1.7; 1.7; 1.7; 1.7; 1.7; 1.7 | — |
| SECONDARY Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline |
0; 0; 3; 0; 0; 1 | — |
| SECONDARY Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions |
4; 0; 7; 0; 0; 0 | — |
| SECONDARY Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions |
5; 0; 0; 0; 1; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Male or non-pregnant/non-lactating females >/=13 years of age (or >/= 18 years of age according to local requirements).
- Received fosamprenavir through prior participation in APV20001, APV30002, APV30003 or PRO30017 or have participated in APV30001 or other studies as deemed appropriate by the project team.
Exclusion Criteria
- Permanent discontinuation of GW433908 in a previous study due to intolerance.
- An active CDC Class C Event.
- Any condition which, in the opinion of the investigator, would preclude a subject from participation.
Data sourced from ClinicalTrials.gov (NCT00296504). 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.