Phase 2
Completed N=99
Effectiveness of Palifermin in Increasing CD4 Counts in Treatment-Experienced HIV Infected Adults
Source: ClinicalTrials.gov NCT00376935 ↗Enrolled (actual)
99
Serious AEs
2.0%
Results posted
Jan 2012
Primary outcomePrimary: Change in Absolute CD4+ Lymphocyte Counts From Baseline (Average of Pre-entry and Entry Values) — 15; 11; 12; 8 cells/mm^3 — p=0.1996
Summary
Palifermin is a modified version of a naturally occurring human growth factor that is currently approved by the FDA to treat blood cancers. The purpose of this study is to determine whether palifermin can increase CD4 counts in treatment-experienced HIV infected adults.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Absolute CD4+ Lymphocyte Counts From Baseline (Average of Pre-entry and Entry Values) |
15; 11; 12; 8 | 0.1996 |
| SECONDARY Qualitative Hepatitis C Virus RNA |
4; 2; 1; 5; 21; 22 | — |
| SECONDARY Grade 3 or 4 Toxicity for Signs and Symptoms From Randomization to Week 24 |
2; 4; 2; 1 | — |
| SECONDARY Change in Naive CD4+ Cell Counts From Randomization |
-2; -2; -1; -2; 0; -2 | — |
| SECONDARY Change in CT Thymic Index From Randomization |
1; 0; 1; 0; 3; 6 | — |
| SECONDARY Change in Absolute CD4+ Lymphocyte Counts From Randomization to Day 2, Weeks 1, 2, 4, 8, 12, 24. |
-4; 2; -12; -5; 1; -12 | — |
| SECONDARY Grade 3 or 4 Lab Toxicities From Randomization to Week 24 |
4; 5; 4; 6 | — |
| SECONDARY Number of Death From Randomization to Week 24 |
0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- HIV infected
- Receiving potent ART, defined as a combination of three or more antiretroviral drugs for at least 6 months prior to study entry
- CD4 count of 200 cells/mm3 or less within 30 days prior to study entry
- Documented CD4 count obtained at study screening
- Documented current, persistent viral load less than or equal to 200 copies/ml for at least 6 months prior to study entry
- Willing to use acceptable forms of contraception for the duration of the study
Exclusion Criteria
- Active pancreatitis
- Androgens, Immunomodulators (e.g., growth factors, systemic corticosteroids, HIV vaccines, immune globulin, interleukins, interferons), or investigational ART within 30 days prior to study entry
- Systemic cancer chemotherapy within 30 days prior to study entry, or history of radiation therapy to the neck and chest regions at any time.
- Allergy or sensitivity to any component of palifermin
- Prior treatment with palifermin or other keratinocyte growth factors
- Current drug or alcohol use that, in the opinion of the investigator, may interfere with study participation
- Serious illness or recent surgery that requires systemic treatment or hospitalization. Participants who have completed therapy or are clinically stable on therapy for at least 30 days prior to study entry are not excluded.
- Active cancer
- HIV-1 RNA levels >200 copies/mL within 6 months prior to study entry
- Pregnant or breastfeeding
Data sourced from ClinicalTrials.gov (NCT00376935). 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.