A Phase 1/2 interventional study of Saquinavir and Ritonavir in HIV Infections, sponsored by Radboud University Medical Center. Completed at 10 sites in 5 countries. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2020-10-19.
Sponsored by Radboud University Medical Center · Phase 1/2, Interventional, and Treatment
Pharmacokinetic study of Saquinavir and Ritonavir in HIV-infected pregnant women
It is generally accepted that HIV-infected pregnant women should receive treatment to prevent the transmission of HIV from mother-to-child.The (relative) contra-indications for the NNRTIs during pregnancy make a PI based regimen the most rational choice. Based on several experiences and investigations it is expected that saquinavir will play a role as a component of tripe drug regimens for HIV-infected pregnant women. Since the bid dose regimen of 1,000mg saquinavir and 100mg ritonavir is approved by the regulatory authorities and with the availability of a new 500mg tablet formulation of saquinavir,there is a need for a well-designed pharmacokinetic trial using the new 500mg saquinavir tablet formulation in the above mentioned dose.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 40 is below the median of 83 across 3,251 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
pharmacokinetics at week 20 and 33 of gestation and 6 weeks post partum
antiviral activity
safety
This study is completed, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.
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Radboud University Medical Center