Structured Treatment Interruptions in Chronic HIV Infection
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|ClinicalTrials.gov Identifier: NCT00324103|
Recruitment Status : Completed
First Posted : May 10, 2006
Last Update Posted : May 10, 2006
|Condition or disease||Intervention/treatment||Phase|
|HIV Infection||Drug: Structured Treatment Interruptions||Phase 3|
Patients are randomized in a 1 to 1 ratio to continue their current antiretroviral regimen (Arm A) or to undergo structured treatment interruptions (STI) (Arm B) according to the following scheme: STIs of 1, 1, 2, 2 and 3 months each followed by a 3-month therapy period.
During STIs, therapy is resumed in the presence of an HIV-RNA rebound > 50,000 copies/ml or of a CD4+ T cell decline > 25% of the baseline count (> 35% for patients with CD4+ > 500/mm3 at randomization). After the first cycle, subsequent STIs are performed only if an HIV-RNA level < 400 copies/ml is reached after 2 months of therapy resumption.
At the time of treatment interruptions patients in arm B who are on treatment with non-nucleoside reverse transcriptase inhibitors suspend these drugs first and continue the treatment with the other drugs of the combination for 3 days if nevirapine-treated and for 6 days in case of previous efavirenz-based regimen.
Patients are seen at the clinical site every three months for arm A and monthly for arm B. On these occasions, blood samples are obtained for biochemical and viro-immunological assessments.
The toxicity grading scale of the AIDS Clinical Trial Group (ACTG) is used for the reporting of clinical and laboratory adverse events.
In arm B, plasma genotype is obtained in samples taken after 15 or 30 days of drug suspension.
Patients will discontinue the study in case of : early therapy resumption for 2 consecutive times (only arm B patients); acute retroviral syndrome (only for arm B patients); AIDS-defining event; severe adverse event; pregnancy; non-compliance; patient’ s request; physician’s decision.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Antiretroviral Treatment With Structured Treatment Interruptions (STI) Versus Continuous Antiretroviral Treatment in HIV+ Patients With Persistent Suppression of Viral Replication|
|Study Start Date :||June 2001|
|Estimated Study Completion Date :||June 2004|
- proportion of patients with CD4+ cell count above 500/mm3 at the end of follow-up (2 years) in the two treatment arms.
- occurrence of grade 3 or 4 adverse events (clinical and laboratory)
- proportion of patients with HIV-RNA < 400 copies/ml at the end of follow-up
- proportion of patients with CD4+ cell count > 350/mm3 at the end of follow-up
- rate of virological failure
- emergence of resistance
- HIV-related events.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00324103
|Istituto Superiore di Sanità|
|Rome, Italy, 00161|
|Study Chair:||Stefano Vella, MD||Istituto Superiore di Sanità|