Phase 4
Completed N=47
A Study to Evaluate the Safety and Efficacy of Adding Enfuvirtide to Oral Highly Active Antiretroviral Therapy (HAART) in Human Immunodeficiency Virus (HIV) Patients With Prior Treatment Experience
Source: ClinicalTrials.gov NCT00487188 ↗Enrolled (actual)
47
Serious AEs
14.9%
Results posted
Sep 2011
Primary outcomePrimary: Number of Participants With Viral Suppression: HIV-1 RNA < 50 Copies/mL During the Induction Phase — 20; 8 Participants
Summary
To assess the efficacy of enfuvirtide (Fuzeon) added to HAART compared to treatment with HAART alone in achieving and maintaining viral load suppression.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Viral Suppression: HIV-1 RNA < 50 Copies/mL During the Induction Phase |
20; 8 | — |
| SECONDARY Time to Achieving HIV-1 RNA < 50 Copies/mL During the Induction Phase |
57.0; 141.0 | — |
| SECONDARY Number of Participants With Viral Suppression HIV-1 RNA < 400 Copies/mL During the Induction Phase |
21; 8 | — |
| SECONDARY Change From Baseline to Week 24 in Viral Load |
-1.402; -1.156 | — |
| SECONDARY Change From Baseline to Week 24 in Cluster Differentiation Antigen Four Positive (CD4+) Cell Counts |
20.81; 17.88 | — |
| SECONDARY Percentage of Induction Phase Participants With Viral Load < 50 Copies/mL at 48 Weeks |
45.2; 25.0 | — |
| SECONDARY Percentage of Maintenance Phase Participants With Viral Load < 50 Copies/mL at 48 Weeks |
73.7; 50.0 | — |
| SECONDARY Change From Baseline to Week 48 in Cluster Differentiation Antigen Four Positive (CD4) Cell Counts |
73.09; 50.79 | — |
| SECONDARY Time to Loss of Viral Response During the Maintenance Phase |
NA; NA | — |
| SECONDARY Time to Virological Failure During the Maintenance Phase |
NA; NA | — |
| SECONDARY Number of Participants With Virological Failure During the Maintenance Phase |
3; 0 | — |
| SECONDARY Percentage of Participants Maintaining CD4+ Count During the Maintenance Phase |
66.67; 75.00; 75.00; 33.33; 25.00; 12.50 | — |
| SECONDARY Percentage of Participants With Improvement in CD4+ Count During the Maintenance Phase |
100.00; 100.00; 0; 0 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) During the Induction Phase |
3; 3; 3; 1; 5; 1 | — |
Eligibility Criteria
Inclusion Criteria
- HIV-1 infected adults >=18 years of age;
- currently on antiretroviral (ARV) therapy;
- previously treated with 2 or 3 different antiretroviral classes;
- HIV-1 Ribonucleic acid (RNA) >=1,000 copies/mL;
- Cluster differentiation antigen four (CD4) lymphocyte count >=200 cells/mm^3;
- females of childbearing potential must be willing to use a reliable form of effective barrier contraception for the duration of the study and for 30 days after the last dose of study drug.
Exclusion Criteria
- history of prior use of enfuvirtide or T-1249;
- women who are pregnant, breastfeeding or planning to become pregnant during the study;
- active, untreated opportunistic infection;
- patients on treatment interruption, or patients interrupting ARV therapy within 4 weeks of screening or during the screening period for reasons either than toxicity management.
Data sourced from ClinicalTrials.gov (NCT00487188). 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.