Status:
COMPLETED
Impact of Raltegravir on HIV-1 cDNA Slope Following Antiretroviral Therapy (ART) Initiation
Lead Sponsor:
Christoph Stephan
Collaborating Sponsors:
University Hospital Heidelberg
Conditions:
HIV-1
Eligibility:
All Genders
18+ years
Brief Summary
Recent clinical trials of combination antiretroviral therapy (cART) containing the first approved integrase inhibitor (i.e. raltegravir) have demonstrated a more rapid decay of HIV-1 RNA in plasma, co...
Eligibility Criteria
Inclusion
- Initiation of antiretroviral therapy, consisting of 2 nucleoside/ nucleotide reverse transcriptase inhibitors at physician's disposition plus a third substance, i.e. either raltegravir (n=10 patients) or a standard third substance (efavirenz or boosted protease inhibitor)
- Men or women with a documented HIV-1 infection, treated at the study center
- age at least 18 years old
- physical examination and vital signs, according to the treating physician do not give any hint for a active AIDS-defining illness or other serious disease
- patients are naive to cART or in therapy interruption for at least 3 months
- last available HIV-1 RNA was \>5,000 copies/mL within 3 months prior to cART initiation
- last available CD4-cell count showed at least 200 cells/µL within 3 months prior to cART initiation
- according to German-Austrian antiretroviral treatment recommendations, there is a given therapy indication
Exclusion
- cART with other than the above mentioned drugs
- administration of concomitant drugs with relevant impact on antiretroviral's pharmacokinetics
- documented problems with patient visit- or medication-adherence
- any condition or disease requiring a medication that may interact relevantly with cART
Key Trial Info
Start Date :
June 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01168167
Start Date
June 1 2010
End Date
May 1 2012
Last Update
March 23 2016
Active Locations (1)
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1
Johann Wolfgang Goethe-University Hospital
Frankfurt am Main, Hesse, Germany, 65520