National Cancer Institute - Cancer.gov

Our Clinical Trials

For further information about any of these clinical trials, please contact Dr. Maldarelli at fmalli@mail.nih.gov.

Analysis of HIV-1 Replication During Antiretroviral Therapy — Protocol #08-I-0221 (NCT007667312)

  • Principal Investigator: Frank Maldarelli, M.D., Ph.D.
  • Status: Open, recruiting
  • Type: Nontherapeutic protocol, observational, evaluation of individuals with HIV fmalli@mail.nih.govinfection undergoing antiretroviral therapy
  • Collaborating Centers: None

Effect of interferon alpha 2b intensification on HIV-1 residual viremia in individuals suppressed on antiretroviral therapy — Protocol #11-I-0057 (NCT01295515) 

  • Principal Investigator: Frank Maldarelli, M.D., Ph.D.
  • Status: Open, not recruiting
  • Type: Interventional study of the effects of interferon alpha 2b on HIV in individuals undergoing antiretroviral therapy
  • Collaborating Centers: University of Pittsburgh Medical Center

A double blind randomized placebo controlled study examining the effects of a non-absorbable (rifaximin) antibiotic on the chronic immune activation observed in HIV-infected subjects — Protocol #13-I-0062 (NCT01866826)

  • Principal Investigator: Frank Maldarelli, M.D., Ph.D.
  • Status: Open, not recruiting
  • Type: Interventional study of the effects of rifaximin on markers of immune activation in HIV-infected individuals undergoing antiretroviral therapy
  • Collaborating Centers: University of Pittsburgh Medical Center, Walter Reed National Medical Center

Research use of human specimens and data for the HIV Dynamics and Replication Program — Protocol #17-I-N051

  • Principal Investigator: Frank Maldarelli, M.D., Ph.D.
  • Status: Open, not recruiting
  • Type: Repository protocol for samples from HIV Dynamics and Replication Program studies that have closed
  • Collaborating Centers: None

Imaging and Biopsy of HIV-Infected Individuals Undergoing Analytic Treatment Interruption — #000277 (NCT05419024)

  • Principal Investigator: Chuen-Yen C Lau, M.D., M.S., MPH
  • Status: Open, Recruiting
  • Type: Analytical Treatment Interruption study to find where HIV-infected cells are located in the body, even when ART is keeping levels low
  • Collaborating Centers: None

Use of combination antiviral therapy to delineate the identity and longevity of persistent reservoirs of HIV-1 infections and replication — Protocol #97-I-0082 (NCT00001644)

  • Principal Investigator: Frank Maldarelli, M.D., Ph.D.
  • Status: Closed
  • Type: Interventional study of the effects of combination antiretroviral therapy on HIV infection
  • Collaborating Centers: None

A randomized placebo controlled trial of atorvastatin in HIV positive patients not on antiretroviral medications with the specific aims of studying the effects of atorvastatin on HIV viral load and immune activation markers — Protocol #06-I-0197 (NCT00367458)

  • Principal Investigator: Frank Maldarelli, M.D., Ph.D.
  • Status: Closed
  • Type: Interventional study of the effect of atorvastatin on HIV RNA levels in infected individuals prior to initiating antiretroviral therapy
  • Collaborating Centers: National Naval Medical Center (now Walter Reed National Military Medical Center)

Analysis of HIV-1 genetic variation in patients prior to initiation of highly active antiretroviral therapy — Protocol #00-I-0110 (NCT007667312)

  • Principal Investigator: Frank Maldarelli, M.D., Ph.D.
  • Status: Closed
  • Type: Interventional study of the HIV genetic variation prior to and following initiation of  antiretroviral therapy
  • Collaborating Centers: None

An assessment of the relationship between antiretroviral drug genotype/phenotype (IC50) and antiretroviral activity in HIV-infected, drug-experienced patients with suboptimal suppression of plasma viral load — Protocol #01-I-0004 (NCT00006494) 

  • Principal Investigator: Frank Maldarelli, M.D., Ph.D.
  • Status: Closed
  • Type: Interventional study of the correlation between phenotype/genotype to selected antiretroviral agents and short-term change in viral load upon discontinuation of a single antiretroviral agent from individuals undergoing antiretroviral therapy who have rebound viremia
  • Collaborating Centers: National Naval Medical Center (now Walter Reed National Military Medical Center)

HIV expression in patients with viral loads suppressed on HAART — Protocol #02-I-0232 (NCT00043641)

  • Principal Investigator: Frank Maldarelli, M.D., Ph.D.
  • Status: Closed
  • Type: Interventional study of the effects of additional antiretroviral therapy on low-level viremia in individuals undergoing antiretroviral therapy
  • Collaborating Centers: University of Pittsburgh Medical Center

For additional information about these completed studies, please contact Dr. Frank Maldarelli at fmalli@mail.nih.gov. 

Frank Maldarelli, M.D., Ph.D. participates as an associate investigator on collaborative protocols within the NCI and National Institute of Allergy and Infectious Diseases (NIAID). He provides clinical assessments as well as analysis of genotypic/phenotypic information, often as part of a weekly Resistance Conference that he chairs. These interactions frequently provide opportunities for additional collaborative efforts and have resulted in several manuscripts as well as a source of ongoing samples for additional studies of HIV drug resistance.

Dr. Maldarelli serves as an associate investigator on the following NIAID clinical trial:

Characterization and management of patients with HIV-1 infection who experience virologic failure despite combination antiretroviral therapy — Protocol #14-I-0009 (NCT01976715)

  • Principal Investigator: Alice Pau, Pharm.D.
  • Status: Open, not recruiting
  • Type: Interventional study of HIV drug resistance in individuals undergoing antiretroviral therapy with rebound viremia
  • Collaborating Centers: None

Dr. Maldarelli serves as an associate investigator on the following collaborative NCI studies of the pathogenesis of neoplasms in HIV infection:

A phase 1 trial of pomalidomide in combination with liposomal doxorubicin in patients with advanced or refractory Kaposi sarcoma — Protocol #16-C-0047 (NCT026559930)

  • Principal Investigator: Ramya M. Ramiswami, M.D.
  • Status: Open, recruiting
  • Type: Interventional study to test a combination of the anticancer drugs pomalidomide and liposomal doxorubicin in people with Kaposi sarcoma
  • Collaborating Centers: None

A phase I/II study of the safety, pharmacokinetics and efficacy of pomalidomide (CC-4047) in the treatment of Kaposi sarcoma in individuals with or without HIV — Protocol #12-C-0047 (NCT01495598)

  • Principal Investigator: Robert Yarchoan, M.D.
  • Status: Open, not recruiting
  • Type: Interventional study to determine whether pomalidomide is a safe and effective treatment for Kaposi sarcoma in people with or without HIV
  • Collaborating Centers: None

A phase I study of MK-3475 (pembrolizumab) in patients with human immunodeficiency virus (HIV) and relapsed/refractory or disseminated malignant neoplasm — Protocol #16-C-0066 (NCT02595866)

  • Principal Investigator: Thomas S. Uldrick, M.D.
  • Status: Open, recruiting
  • Type: Interventional study of the side effects of pembrolizumab in treating patients with HIV and malignant neoplasms that have come back (relapsed), do not respond to treatment (refractory), or have distributed over a large area in the body (disseminated)
  • Collaborating Centers: Participating centers in the Cancer Immunotherapy Trials Network

A Pilot Study to Evaluate the Feasibility, Safety and Engraftment of Zinc Finger Nucleases (ZFN) CCR5 Modified CD34+ Hematopoietic Stem/Progenitor Cells (SB-728MR-HSPC) in HIV-1 (R5) Infected Patients — Protocol #15-C-0078 (NCT0250089)

  • Principal Investigators: Mark J. Roschewski, M.D. (NCI); Amrita Y. Krishnan, M.D. (City of Hope Medical Center)
  • Status: Open, not recruiting
  • Type: Interventional study to evaluate the safety and feasibility of giving autologous SB-728mR-HSPC to HIV-infected patients who are being treated with combination antiretroviral therapy and have undetectable virus but suboptimal CD4+ cell levels
  • Collaborating Centers: City of Hope Medical Center, Sangamo Therapeutics, California Institute for Regenerative Medicine

In these NCI studies, Dr. Maldarelli participates in clinical discussion of the patients, as well as performs laboratory studies with the HIV Molecular Monitoring Core to quantify and characterize HIV populations in individuals undergoing chemotherapy or transplantation. Such studies provide critical information regarding the state of HIV infection in individuals with comorbid neoplasms undergoing suppressive antiretroviral therapy as well as chemotherapy. These studies also provide useful information regarding the response of HIV to chemotherapy, shedding new light on HIV persistence.

In 2011, the clinical group of the Host-Virus Interaction Branch (HVIB) recruited 30 patients with severe chronic fatigue syndrome and 30 controls for the study of XMRV using an existing tissue procurement protocol (Specimen Collections From Patients With HIV Infection, KSHV Infection, Viral-Related Pre-malignant Lesions and Cancer, 01-C-0038, NCT00898651) made available to the HVIB by the protocol chair, Dr. Robert Yarchoan, NCI HIV and AIDS Malignancy Branch (HAMB). Recruitment, enrollment, and clinical evaluation of these patients have been managed by the HVIB with strong study coordinator assistance by HAMB staff. The study is completed, but samples stored from this study, which were useful in demonstrating that XMRV was a specimen contaminant and not a human pathogen, are now available for other studies as control samples from individuals without HIV infection.