The Safety and Effectiveness of Two Forms of Saquinavir Combined With Other Anti-HIV Drugs in HIV-Infected Infants and Children

Back to results

Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Nelfinavir mesylate

Saquinavir

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, HIV Protease Inhibitors, Dosage Forms, Saquinavir, Nelfinavir, Anti-HIV Agents

Eligibility Criteria

6 Months - 13 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria Patients must have: HIV infection according to standard definitions employed by the Pediatric AIDS Clinical Trials Group. Laboratory evidence of immunosuppression (Centers for Disease Control and Prevention [CDC] categories 2 and 3), or symptomatic HIV disease (CDC categories A, B, and C). At least 4 patients (2 in each parts 1 and 2) will be enrolled in each of three age strata: 6 months to 2 years; greater than 2 years to 6 years; and greater than 6 years to 13 years. NOTE: For the purposes of analysis only, patients will be stratified by age. 1. Patients must be protease inhibitor therapy naive. Antiretroviral agents other than those prescribed by the investigator. Biologic response modifiers (other than erythropoietin, G-CSF, short course [<14 days] corticosteroids, or intravenous immune globulin). Other investigational drugs. Drugs known to significantly interact with saquinavir and/or nelfinavir. Patients must be protease inhibitor therapy naive.

Sites / Locations

Hoffmann - La Roche Inc

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00002380

First Posted

November 2, 1999

Last Updated

June 23, 2005

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT00002380

Brief Title

The Safety and Effectiveness of Two Forms of Saquinavir Combined With Other Anti-HIV Drugs in HIV-Infected Infants and Children

Official Title

A Phase I/II Pharmacokinetic and Safety Study of Saquinavir Soft Gelatin Capsules and Pediatric Pellet Formulations in Combination With Nucleoside Antiretroviral Agents With or Without Nelfinavir, in HIV-Infected Infants and Children

Study Type

Interventional

2. Study Status

Record Verification Date

August 1997

Overall Recruitment Status

Completed

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

5. Study Description

Brief Summary

To determine the pharmacokinetic properties, tolerance and safety of 2 formulations of saquinavir, given in combination with 2 nucleoside antiretroviral drugs (part 1) or in combination with nelfinavir and nucleoside antiretroviral drugs (part 2), in HIV-infected infants and children.

Detailed Description

This Phase I/II study will be conducted in 2 parts each lasting at least 24 weeks. Pharmacokinetics and safety data for part 1, a treatment regimen containing saquinavir and nucleoside antiretrovirals, will be collected for 8 weeks before proceeding to part 2. During the first 8 weeks, pharmacokinetic data will be analyzed to allow dose adjustments for individual patients and to confirm the starting dose estimates for part 2. In addition, safety data will be reviewed to ensure that saquinavir is well tolerated with nucleoside antiretrovirals before it is combined with a second protease inhibitor. In part 2, saquinavir will be combined with nelfinavir, a protease inhibitor recently approved for use in children. The pharmacokinetics and safety profile of these drugs in combination will be determined.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

Drug Therapy, Combination, HIV Protease Inhibitors, Dosage Forms, Saquinavir, Nelfinavir, Anti-HIV Agents

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Masking

None (Open Label)

Enrollment

28 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Nelfinavir mesylate

Intervention Type

Drug

Intervention Name(s)

Saquinavir

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

13 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria Patients must have: HIV infection according to standard definitions employed by the Pediatric AIDS Clinical Trials Group. Laboratory evidence of immunosuppression (Centers for Disease Control and Prevention [CDC] categories 2 and 3), or symptomatic HIV disease (CDC categories A, B, and C). At least 4 patients (2 in each parts 1 and 2) will be enrolled in each of three age strata: 6 months to 2 years; greater than 2 years to 6 years; and greater than 6 years to 13 years. NOTE: For the purposes of analysis only, patients will be stratified by age. 1. Patients must be protease inhibitor therapy naive. Antiretroviral agents other than those prescribed by the investigator. Biologic response modifiers (other than erythropoietin, G-CSF, short course [<14 days] corticosteroids, or intravenous immune globulin). Other investigational drugs. Drugs known to significantly interact with saquinavir and/or nelfinavir. Patients must be protease inhibitor therapy naive.

Facility Information:

Facility Name

Hoffmann - La Roche Inc

City

Nutley

State/Province

New Jersey

ZIP/Postal Code

071101199

Country

United States

HIV Infections

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial