Impact of Raltegravir on HIV-1 cDNA Slope Following Antiretroviral Therapy (ART) Initiation
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ClinicalTrials.gov Identifier: NCT01168167 |
Recruitment Status
:
Completed
First Posted
: July 23, 2010
Last Update Posted
: March 23, 2016
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Tracking Information | |||
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First Submitted Date | July 21, 2010 | ||
First Posted Date | July 23, 2010 | ||
Last Update Posted Date | March 23, 2016 | ||
Study Start Date | June 2010 | ||
Actual Primary Completion Date | March 2011 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures |
Dynamical measurement of HIV-1 DNA-species extracted from whole blood-PBMCs [ Time Frame: one year ] | ||
Original Primary Outcome Measures | Same as current | ||
Change History | Complete list of historical versions of study NCT01168167 on ClinicalTrials.gov Archive Site | ||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||
Current Other Outcome Measures | Not Provided | ||
Original Other Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title | Impact of Raltegravir on HIV-1 cDNA Slope Following Antiretroviral Therapy (ART) Initiation | ||
Official Title | Comparing the Dynamics of Different HIV-1 cDNA Species in CD4-positive T-cells and HIV-1 RNA in Plasma of Infected Individuals After Initiation of Antiretroviral Therapy With or Without Raltegravir | ||
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, compared to conventional potent antiretroviral combinations. This was observed especially during the early phase (up to week 12) following initiation of cART. To explain this, two mechanistic hypotheses have been developed:
Patient disposition: To explore raltegravir-induced shifts in HIV-1 cDNA species in vivo, this non-interventional clinical observation investigates the dynamics of the three major HIV-1 cDNA species (total HIV-1 cDNA, HIV-1 integrants in the host cell genome, episomal HIV-1 2-LTR circles) over a period of 4 months in two groups of patients starting off cART from a single study center. Patients who begin cART in regular clinical routine with 2N(t)RTI plus either (n=10 patients) raltegravir or (n=10 patients) a boosted protease inhibitor/ alternatively an NNRTI will be offered to participate in this observation. Only patients are offered to participate in this trial if no other antiretroviral drugs than the above mentioned and no concomitant drugs with relevant impact on antiretroviral's pharmacokinetics are administered. At time of study inclusion, patients should be characterised by a HIV-1 RNA load of >5,000 copies/mL and CD4-cell count of >200/µL within 12 weeks before cART initiation. Preliminary analyses of PBMCs from HIV-infected patients indicate that all three major HIV-1 cDNA species can be quantified by real-time PCR under these baseline conditions. |
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Detailed Description | Not Provided | ||
Study Type | Observational | ||
Study Design | Observational Model: Case Control Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||
Biospecimen | Not Provided | ||
Sampling Method | Non-Probability Sample | ||
Study Population | Patients who begin cART in regular clinical routine with 2N(t)RTI plus either (n=10 patients) raltegravir or (n=10 patients) a boosted protease inhibitor/ alternatively an NNRTI as third substance will be offered to participate in this non-interventional study. Observation time is a period of 4 months after cART initiation. | ||
Condition | HIV-1 | ||
Intervention | Not Provided | ||
Study Groups/Cohorts |
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Publications * | Stephan C, Baldauf HM, Barry J, Giordano FA, Bartholomae CC, Haberl A, Bickel M, Schmidt M, Laufs S, Kaderali L, Keppler OT. Impact of raltegravir on HIV-1 RNA and DNA forms following initiation of antiretroviral therapy in treatment-naive patients. J Antimicrob Chemother. 2014 Oct;69(10):2809-18. doi: 10.1093/jac/dku213. Epub 2014 Jun 23. | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status | Completed | ||
Actual Enrollment |
20 | ||
Original Estimated Enrollment | Same as current | ||
Actual Study Completion Date | May 2012 | ||
Actual Primary Completion Date | March 2011 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | ||
Accepts Healthy Volunteers | No | ||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries | Germany | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number | NCT01168167 | ||
Other Study ID Numbers | JWG-HIVCENTER-Hopp1 | ||
Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | Not Provided | ||
Responsible Party | Christoph Stephan, Johann Wolfgang Goethe University | ||
Study Sponsor | Christoph Stephan | ||
Collaborators | University Hospital Heidelberg | ||
Investigators | Not Provided | ||
PRS Account | Goethe University | ||
Verification Date | March 2016 |