HIV Infection Clinical Trial
Official title:
A Phase II Study of Gamma Secretase Inhibitor PF-03084014 in Patients With AIDS-Associated Kaposi Sarcoma
This phase II trial studies the effects, good and bad, of gamma secretase inhibitor PF-03084014 and to see how well it works in treating patients with acquired immune deficiency virus (AIDS)-associated Kaposi sarcoma. Gamma secretase inhibitor PF-03084014 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and may shrink the tumor.
PRIMARY OBJECTIVES:
I. Evaluate the tolerance and clinical response of Kaposi sarcoma (KS) tumors to PF-03084014
(gamma secretase inhibitor PF-03084014) with assessments of partial response (PR) and
complete response (CR).
SECONDARY OBJECTIVES:
I. Assess the effect of PF-03084014 on human immunodeficiency virus (HIV) viral load in
plasma and the effect of PF-03084014 on cluster of differentiation (CD)4+ cell number.
II. Assess the effect of PF-030840414 in peripheral blood mononuclear cells (PBMCs) and
tumors on Kaposi's sarcoma-associated herpesvirus (KSHV) latent and lytic gene expression.
III. Assess effects of PF-03084014 on activation of Notch target genes including
tumor-associated endothelial-mesenchymal transition and cell proliferation markers.
IV. Assess effects of trough PF-03084014 drug levels on clinical response and toxicity.
OUTLINE:
Patients receive gamma secretase inhibitor PF-03084014 orally (PO) twice daily (BID) on days
1-21. Treatment repeats every 21 days for up to 4 courses in the absence of disease
progression or unacceptable toxicity. Patients with PR, CR, or stable disease (SD) at the
end of 4 courses may receive an additional 4 courses of gamma secretase inhibitor
PF-03084014 in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 28 days.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT02135419 -
Treatment in Preventing Anal Cancer in Patients With HIV and Anal High-Grade Lesions
|
Phase 3 | |
Active, not recruiting |
NCT02663856 -
My Smart Age With HIV: Smartphone Self-assessment of Frailty
|
||
Completed |
NCT02663869 -
Aging With HIV at Younger vs Older Age: a Diverse Population With Distinct Comorbidity Profiles
|
||
Terminated |
NCT02743598 -
Liraglutide for HIV-associated Neurocognitive Disorder
|
Phase 4 | |
Completed |
NCT02846402 -
Impact of HIV Self-testing Among Female Sex Workers in Kampala, Uganda
|
N/A | |
Completed |
NCT02921516 -
Growing Up: Intervening With HIV-Positive Adolescents in Resource-Poor Settings
|
N/A | |
Completed |
NCT02659306 -
Metformin Immunotherapy in HIV Infection
|
Phase 1 | |
Completed |
NCT02564341 -
Targeting Effective Analgesia in Clinics for HIV - Intervention
|
N/A | |
Active, not recruiting |
NCT02302950 -
A Retrospective Analysis of Raltegravir Use in Minority HIV Infected Women in Houston, Texas
|
N/A | |
Completed |
NCT01852942 -
Reversing Tissue Fibrosis to Improve Immune Reconstitution in HIV
|
Phase 2 | |
Completed |
NCT02269605 -
Bryostatin-1 Effect on HIV-1 Latency and Reservoir in HIV-1 Infected Patients Receiving Antiretroviral Treatment
|
Phase 1 | |
Completed |
NCT01830595 -
Lactoferrin Treatment in HIV Patients
|
Phase 2 | |
Terminated |
NCT02109224 -
Ibrutinib in Treating Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma in Patients With HIV Infection
|
Phase 1 | |
Terminated |
NCT01902186 -
Bone Mineral Density Changes in HIV-positive Females With Osteopenia Switching to Raltegravir
|
Phase 4 | |
Completed |
NCT01946217 -
Factors Affecting Patient Participation in AIDS Malignancy Clinical Trials Consortium Clinical Trials
|
N/A | |
Completed |
NCT02525146 -
Birmingham Access to Care Study
|
N/A | |
Completed |
NCT02118168 -
Observational Study for the Extended Follow-up of the Patients Enrolled in the Therapeutic Clinical Trial ISS T-002
|
N/A | |
Completed |
NCT02527135 -
Text Messaging to Improve HIV Testing Among Young Women in Kenya
|
N/A | |
Active, not recruiting |
NCT02602418 -
Neural Correlates of Working Memory Training for HIV Patients
|
N/A | |
Completed |
NCT01702974 -
Immune Reconstitution in HIV Disease (IREHIV)
|
Phase 2 |