Safety and Durability ofTenofovir and a Cell Cycle Agent for Viral Suppression

NCT00344981 | Completed DMC

• 1 other identifier: H-22407
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

Study Hypothesis Evaluation of the durability of the combination Tenofovir and Hydroxyurea to maintain viral suppression below 50 copies/ml in volunteers who have achieved viral suppression on a standard HAART regimen.

Conditions

HIV Infections; AIDS

Keywords

Cell Cycle Agents

Outcome Measures

Primary Outcomes (1)

• Loss of viral suppression during maintenance therapy, defined by 3 consecutive viral load measurements greater than 50c/ml over a 48- week period.

  Viral load measurements will be done throughout the study to monitor for viral suppression

  At any point during the 48 week study

Secondary Outcomes (1)

• Laboratory Abnormalities: Routine measurements of hematology, serum chemistry, CD4 cell count, lipid profiles, and HIV-1 viral load will be performed. Viral genotypes will be performed with failure to maintain viral suppression.

  Throughout the 48 week study

Interventions

Tenofovir DRUG

Half of the 20 volunteers will be randomized to the Tenofovir 300 mg qd/Hydroxyurea 500mg qd arm and those subjects will have Hydroxyurea added to their current screening regimen for 4 weeks prior to de-intensifying to Hydroxyurea and Tenofovir.

Also known as: Viread

Hydroxyurea DRUG

Half of the 20 volunteers will be randomized to the Tenofovir 300 mg qd/Hydroxyurea 500mg qd arm and those subjects will have Hydroxyurea added to their current screening regimen for 4 weeks prior to de-intensifying to Hydroxyurea and Tenofovir. Volunteers will continue on this regimen for 48 weeks. Patients will be monitored for immunological and virological parameters as well as the incidence of toxicity and side effects during the study. If a patient's viral load reaches \>400 copies/ml on 3 consecutive measurements over a 6 week period, they will be terminated from the study and started back on their HAART.

Also known as: Hydrea

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of HIV infection based on western blot testing, ELISA, or HIV viral load
• Age greater than or equal to 18 years
• CD4 count greater than or equal to 200c/ml.
• On a standard HAART regimen of 2 or 3 nucleoside reverse transcriptase inhibitors and either a protease inhibitor or a nonnucleoside reverse transcriptase inhibitor or 3 nucleoside reverse transcriptase inhibitors (2-3NRTI's + PI or 2-3NRTI's +NNRTI or 3NRTI's).
• On stable, continuous HAART regimen for greater than or equal to 3 months,
• Viral load less than or equal to 400c/ml on all measurements in the preceding 6 months with at least 2 measurements (screening viral load can be included if needed)
• Viral load less than or equal to 50c/ml at screening
• Subject able to comply with the study protocol
• Signed informed consent
• No history of antiretroviral failure that is suspected to be from or resulted in antiretroviral resistance.

You may not qualify if:

• Serious HIV related or non HIV related carcinoma requiring chemotherapy
• Recent serious opportunistic infection, such as progressive multifocal leukoencephalopathy, CMV disease, cryptococcus meningitis, cerebral toxoplasmosis, but not excluding other infections in which successful treatment may be judged to be placed at risk if antiretroviral therapy was de intensified.
• Known or suspected intolerance or hypersensitivity to Hydroxyurea
• Grade 3 or higher neutropenia (using ACTG grading table)
• Grade 2 or higher thrombocytopenia (using ACTG grading table)
• Grade 2 or higher LFT abnormalities (using ACTG grading table)
• History of pancreatitis, or risk factors associated with pancreatitis (more then two drinks containing alcohol/day, triglyceride levels greater than 400, and pancreatic enzymes greater then 1.5x normal)
• Renal insufficiency (Estimated Creatinine clearance of \<60ml/min.)
• Chronic diarrhea
• Pregnancy or breastfeeding
• Unwillingness to use effective barrier contraception or abstinence
• The use of systemic corticosteroids, or other systemic immunosuppressive medications; the use of cholestyramine; the use of probenecid or other inhibitors of renal tubular secretion
• Genotypic or phenotypic testing documenting major resistance to any antiretroviral agents
• Active substance or mental health concerns that are judged to place a significant limitation on medication adherence.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland, Institute of Human Virology

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Tenofovir; Hydroxyurea

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Urea; Amides

Study Officials

• Robert R. Redfield, MD

  University of Maryland, School of Medcine, Department of Infectious Disease

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 23, 2006
• First Posted: June 27, 2006
• Study Start: June 1, 2003
• Primary Completion: November 1, 2006
• Study Completion: November 1, 2006
• Last Updated: May 11, 2021

Record last verified: 2021-05

Locations

US (1)