Safety and Effectiveness of Adding Saquinavir (FORTOVASE) in Soft Gel Capsule Form to an Anti-HIV Drug Combination in HIV-Infected Patients - Tabular View

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Safety and Effectiveness of Adding Saquinavir (FORTOVASE) in Soft Gel Capsule Form to an Anti-HIV Drug Combination in HIV-Infected Patients

This study has been completed.

Study NCT00002229. Last updated on June 23, 2005. Information provided by NIH AIDS Clinical Trials Information Service

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Safety and Effectiveness of Adding Saquinavir (FORTOVASE) in Soft Gel Capsule Form to an Anti-HIV Drug Combination in HIV-Infected Patients

Official Title ^†

A Phase IV, Non-Comparative Study to Evaluate FORTOVASE (Saquinavir) Soft Gel Capsule (SGC) TID Regimen in Combination With Two NRTI's in HIV-1 Infected Women and Men

Brief Summary

The purpose of this study is to see if it is safe and effective to give saquinavir (as a soft gel capsule taken by mouth) along with 2 other anti-HIV drugs to HIV-infected patients.

Detailed Description

Prior to initiation of study treatment all patients are screened and baseline lab values are taken. Patients then receive the study treatment, FORTOVASE, two times a day plus 2 new NRTI's. Assessments will be performed at specified intervals throughout the duration of treatment.

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Open Label, Pharmacokinetics Study

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

HIV Infections

Intervention ^†

Drug: Saquinavir

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

Completion Date

Eligibility Criteria ^†

Inclusion Criteria

You may be eligible for this study if you:

Are HIV-positive.
Have an HIV count of 5,000 copies/ml or more.
Have a CD4 count of 100 cells/mm3 or more.
Meet specific requirements if you have ever taken NRTIs.
Are 16 - 64 years old (need consent if under 18).
Agree to use effective methods of birth control during the study.

Exclusion Criteria

You will not be eligible for this study if you:

Have taken non-nucleoside reverse transcriptase inhibitors (NNRTIs) or protease inhibitors (PIs) for more than 2 weeks.
Have taken all the available NRTIs.
Have certain serious medical conditions, including severe liver disease or active opportunistic (AIDS-related) infection.
Have a history of weight loss, muscle pain, and loss of appetite.
Have taken certain medications, including anti-HIV drugs other than those required by this study.
Are pregnant or breast-feeding.
Abuse alcohol or drugs.
Are unable to complete the study for any reason.

Gender

Both

Ages

16 Years to 64 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States, Canada, Puerto Rico

Administrative Information Fields

NCT ID ^†

NCT00002229

Organization ID

229Q

Secondary IDs ^††

NR15750

Study Sponsor ^†

Hoffmann-La Roche

Collaborators ^††

Investigators ^†

Study Chair:	S Palleja
Study Chair:	C Karol

Information Provided By

NIH AIDS Clinical Trials Information Service

Verification Date

December 1999

First Received Date ^†

November 2, 1999

Last Updated Date

June 23, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.