HIV Infections
Conditions
Keywords
HIV
Brief summary
Pharmacokinetic study of Saquinavir and Ritonavir in HIV-infected pregnant women
Detailed description
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.
Interventions
Sponsors
Hoffmann-La Roche
Radboud University Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* HIV infected woman * 18 - 40 years of age * able and willing to sign Informed Consent * pregnant for a maximum of 31 weeks
Exclusion criteria
* history of sensitivity/idiosyncrasy to the drug * relevant history of interference with drug metabolism * inability to understand trial procedures * abnormal specific serum levels * use of specific concomitant medications * active hepatobiliary or hepatic disease * previous failure of saquinavir/ritonavir regimen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pharmacokinetics at week 20 and 33 of gestation and 6 weeks post partum | — |
Secondary
| Measure | Time frame |
|---|---|
| antiviral activity | — |
| safety | — |
Countries
Germany, Netherlands, Spain, Thailand, United Kingdom
Outcome results
None listed