Phase 3
Completed N=52
Evaluating the Effect of CHanging EnfuvirtidE to Raltegravir in HIV Infected Subjects
Source: ClinicalTrials.gov NCT00529243 ↗Enrolled (actual)
52
Serious AEs
5.8%
Results posted
Jun 2011
Primary outcomePrimary: Number of Patients With Undetectable Human Immunodeficiency Virus (HIV) Viral Load at Week 24. — 49 participants
Summary
The primary objective of this study is:
To assess the virologic effect of changing enfuvirtide to MK-0518(raltegravir) in human immunodeficiency virus type 1(HIV-1) infected patients who have an undetectable level of serum human immunodeficiency virus(HIV) (< 75 copies/ml by branch deoxyribonucleic acid (bDNA) assay, < 50 copies/ml by Ultrasensitive Polymerase Chain Reaction(PCR) assay) on their current HIV medication regimen.
Hypothesis:
HIV-1 infected individuals well controlled on an enfuvirtide containing regimen with HIV RNA levels below limits of quantification can safely have the investigational integrase inhibitor, MK-0518 substituted for enfuvirtide without loss of virologic suppression.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Undetectable Human Immunodeficiency Virus (HIV) Viral Load at Week 24. |
49 | — |
| SECONDARY Average Change in Cluster of Differentiation 4(CD4) Cell Count From Baseline at Week 24 |
32 | — |
Eligibility Criteria
Inclusion Criteria
- Patients must meet all of the following inclusion criteria to be eligible for participation in this study.
- Subject is ≥ 18 years of age and able to understand and willing to sign a written informed consent form, which must be obtained prior to initiation of the study.
- Documented laboratory diagnosis of HIV-1 infection (positive Enzyme-linked immunosorbent assay (ELISA) HIV-1 antibody test confirmed by western blot, p24 assay, HIV-1 RNA, or culture).
- Have documented plasma HIV-1 RNA level(s) of 75 copies/ml by bDNA assay, or > 50 copies/ml by Ultrasensitive PCR assay in the 6 months prior to screening visit (A single "blip" of HIV-1 viral load >75 copies but 50 copies but 2.0 or calculated creatinine clearance < 40 ml/min
- Female patient who is pregnant or breast-feeding, or expecting to conceive or donate eggs during the study. Male patient who is planning to impregnate or provide sperm donation during the study.
Data sourced from ClinicalTrials.gov (NCT00529243). 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.