Salvage Treatment, Resistance Testing, and Withdrawal of Anti-HIV Drugs for HIV Patients Failing … (NCT00011128) | Clinical Trial Compass
WithdrawnPhase 3
Salvage Treatment, Resistance Testing, and Withdrawal of Anti-HIV Drugs for HIV Patients Failing Current Anti-HIV Treatment
United States0
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria
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.
Exclusion Criteria
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.
Trial details
NCT IDNCT00011128
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)