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

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Maryland; University of Maryland, Baltimore
• Treatments: Hydroxyurea; Tenofovir

Criteria

Inclusion Criteria:

1. Diagnosis of HIV infection based on western blot testing, ELISA, or HIV viral load

2. Age greater than or equal to 18 years

3. CD4 count greater than or equal to 200c/ml.

4. 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).

5. On stable, continuous HAART regimen for greater than or equal to 3 months,

6. 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)

7. Viral load less than or equal to 50c/ml at screening

8. Subject able to comply with the study protocol

9. Signed informed consent

10. No history of antiretroviral failure that is suspected to be from or resulted in antiretroviral resistance.

Exclusion Criteria:

1. Serious HIV related or non HIV related carcinoma requiring chemotherapy

2. 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.

3. Known or suspected intolerance or hypersensitivity to Hydroxyurea

4. Grade 3 or higher neutropenia (using ACTG grading table)

5. Grade 2 or higher thrombocytopenia (using ACTG grading table)

6. Grade 2 or higher LFT abnormalities (using ACTG grading table)

7. 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)

8. Renal insufficiency (Estimated Creatinine clearance of <60ml/min.)

9. Chronic diarrhea

10. Pregnancy or breastfeeding

11. Unwillingness to use effective barrier contraception or abstinence

12. 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

13. Genotypic or phenotypic testing documenting major resistance to any antiretroviral agents

14. Active substance or mental health concerns that are judged to place a significant limitation on medication adherence.