HIV-1 Infection/AIDS MedDRA version: 9.1 Level: LLT Classification code 10020192 Term: HIV-1
Conditions
Interventions
Trade Name: INVIRASE®
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: saquinavir
Current Sponsor code: RO 031-8959/008
Concentration unit: mg milligram(s)
Concentration type: equal
Concentrati
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Confirmed HIV-1 infection by HIV-DNA polymerase chain reaction (PCR) if patient 18 months old. 2. Patient is 4 months to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patient whose weight is less than 4 kg / 8.8 pounds (screening visit). 2. History of sensitivity/idiosyncrasy to saquinavir mesylate, ritonavir, or chemically related compounds or excipients which may be employed in the trial. 3. Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion. 4. Any current clinical or laboratory parameter of PACTG Grade 4. 5. Use of any concomitant medications that may interfere with the pharmacokinetics of saquinavir or ritonavir, including but not limited to the drugs listed below, within 28 days prior to the first dose of study drug: • Clarithromycin • Indinavir • Ketaconazole • Nelfinavir • Rifabutin • Rifampicin • Atazanavir • Fosamprenavir • Phenobarbital • Phenytoine • Carbamazepine • Glucocortocoids 6. Any active opportunistic infection and/or clinically significant finding within 28 days before study entry (screening visit). 7. Patients with malabsorption, (severe chronic diarrhea or vomiting more than two episodes of moderate or severe intensity, not attributed to medication therapy and lasting more than four days) within 28 days of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: • To characterize the pharmacokinetics of ritonavir when given as a booster in combination with saquinavir in HIV-1 infected infants and children 4 months to < 6 years. • To evaluate the antiviral activity of saquinavir when boosted with ritonavir against HIV-1 infection in infants and children 4 months to < 6 years.;Primary end point(s): • The primary parameters are AUC0-12h and Ctrough for saquinavir. • Frequency and type of Adverse Effects and laboratory parameters (including change from baseline) at 24 weeks and 48 weeks.;Main Objective: • To evaluate the pharmacokinetics of saquinavir that, when boosted with ritonavir, provides a systemic exposure in HIV-1 infected infants and children 4 months to < 6 years similar to that which has been shown to be safe and effective in older children and adults. • To determine the safety and tolerability of saquinavir when boosted with ritonavir in HIV-1 infected infants and children 4 months to < 6 years of age. | — |
Countries
United Kingdom
Outcome results
None listed