Salvage Treatment, Resistance Testing, and Withdrawal of Anti-HIV Drugs for HIV Patients Failing Current Anti-HIV Treatment

Withdrawn before enrolling · Phase 3

Conditions studied: HIV Infections

In brief

The purpose of this study is to test another way to control the amount of HIV in the blood (viral load). Studies show that stopping all anti-HIV drugs for a time before switching to new anti-HIV drugs may improve the response in some individuals who are failing treatment. Other studies suggest a benefit if drug-resistance tests are used in selecting a new anti-HIV drug treatment. This study tests the effect of stopping anti-HIV drugs for a time before switching to anti-HIV drugs selected using drug-resistance test results.

Key facts

Study ID

NCT00011128

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

0

Last updated by the study team

2015-05-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients may be eligible for this study if they:
• Are HIV-infected.
• Are likely to have drug-resistant HIV from having taken all types of anti-HIV drugs (protease inhibitors [PIs], nucleoside reverse transcriptase inhibitors [NRTIs], and nonnucleoside reverse transcriptase inhibitors [NNRTIs]), and having failed treatment prior to the current treatment for reasons other than toxicity.
• Are currently receiving anti-HIV treatment with at least 3 drugs. Low doses of ritonavir (100 to 200 mg twice daily) taken with 1 other PI is counted as a single PI.
• Are currently failing treatment due to a high viral load (amount of HIV in the blood).
• Have had a new anti-HIV drug combination selected.
• Are at least 18 years old.
• This study has been changed to remove CD4 counts as an inclusion criterion. In the previous version of the protocol, patients were required to have a CD4 count of 150 cells/ml or more within 42 days prior to study entry.

You may not qualify if…

• Patients will not be eligible for this study if they:
• Have stopped treatment for more than 4 weeks in the past 6 months.
• Are pregnant or breast-feeding.
• Have cancer that requires systemic treatment or radiation.
• Have received the following medications affecting the immune system within 14 days before entry: erythropoietin; Granulocyte Colony Stimulating Factor (G-CSF), including Granulocyte Macrophage Colony Stimulating Factors (GM-CSF); interleukins; or therapeutic HIV vaccines.

Where it is running

• Univ of Alabama at Birmingham — Birmingham, Alabama, United States
• UCLA CARE Ctr — Los Angeles, California, United States
• Willow Clinic — Menlo Park, California, United States
• Univ of California, San Diego — San Diego, California, United States
• San Mateo AIDS Program / Stanford Univ — Stanford, California, United States
• Stanford Univ Med Ctr — Stanford, California, United States
• Univ of Colorado Health Sciences Ctr — Denver, Colorado, United States
• Univ of Miami School of Medicine — Miami, Florida, United States
• Univ of Hawaii — Honolulu, Hawaii, United States
• Rush Presbyterian - Saint Luke's Med Ctr — Chicago, Illinois, United States
• The CORE Ctr — Chicago, Illinois, United States
• Indiana Univ Hosp — Indianapolis, Indiana, United States
• Methodist Hosp of Indiana / Life Care Clinic — Indianapolis, Indiana, United States
• Wishard Hosp — Indianapolis, Indiana, United States
• Beth Israel Deaconess - West Campus — Boston, Massachusetts, United States
• SUNY / Erie County Med Ctr at Buffalo — Buffalo, New York, United States
• Beth Israel Med Ctr — New York, New York, United States
• Cornell Clinical Trials Unit - Chelsea Clinic — New York, New York, United States
• Bellevue Hosp / New York Univ Med Ctr — New York, New York, United States
• Cornell Univ Med Ctr — New York, New York, United States
• Columbia Presbyterian Med Ctr — New York, New York, United States
• Community Health Network Inc — Rochester, New York, United States
• Univ of Rochester Medical Center — Rochester, New York, United States
• Duke Univ Med Ctr — Durham, North Carolina, United States
• Univ of Cincinnati — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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