HIV InfectionsPhase 3NCT00002397

A Study of Saquinavir Soft Gel Capsules (SGC) Used in Combination With Two Other Anti-HIV Drugs in Patients With HIV-Associated Kidney Disease

A Phase 3 study testing Nelfinavir mesylate, Saquinavir and Lamivudine in people with HIV Infections and AIDS-Associated Nephropathy, run by Hoffmann-La Roche at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV Infections, AIDS-Associated Nephropathy
What is being tested?: Nelfinavir mesylate, Saquinavir and Lamivudine
How many people: 24 participants
Where: 1 siteUnited States
Study dates: Start not givento not given
Phase: Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients must have:
Detectable HIV-1 RNA by Amplicor assay.
Biopsy-proven nephropathy.

Who cannot join

Prior Medication:
Excluded:
Saquinavir and nelfinavir.
d4T or 3TC within the past 4 months.
Required:
Stable antiretroviral therapy for more than 4 weeks.

Trial locations and contacts

1 site in 1 country.

United States1 site

Mount Sinai Med Ctr
New York, New York, 10029

Other trials in United States

About this study

Official title: An Exploratory Study of Fortovase (Saquinavir) Soft Gelatin Capsules (SGC) Plus d4T and 3TC or Fortovase (Saquinavir) SGC Plus Nelfinavir and d4T in Patients With HIV-1 Associated Nephropathy

The purpose of this study is to compare the safety and effectiveness of saquinavir SGC plus stavudine (d4T) plus lamivudine (3TC) with that of saquinavir SGC plus nelfinavir plus d4T in patients with HIV-associated kidney disease. This study examines whether these drug combinations are effective in preventing kidney disease from progressing to a stage where it is immediately life threatening. This study also examines the effect these drug combinations have on the level of HIV detected in these patients. Finally, this study evaluates the drug level (the amount of drug found in the body) of these two combinations in patients with kidney disease.

Read the detailed description

This is an open-label, non-comparative, randomized, single center, 24-week study. Patients are stratified into 3 groups (8 patients in each group) based on kidney function:

Group 1: Serum creatine less than 2 mg/dL. Group 2: Serum creatine 2-5 mg/dL. Group 3: Serum creatine greater than 5 mg/dL.

All 24 patients are randomized 1:1 to receive 1 of 2 study regimens:

Arm A: Saquinavir SGC plus d4T plus 3TC. Arm B: Saquinavir SGC plus nelfinavir plus d4T. Patients are seen at Weeks 4, 8, 12, and 24. At Week 24, a kidney biopsy is performed with patient consent.

Conditions: HIV Infections, AIDS-Associated Nephropathy
Being tested: Nelfinavir mesylate, Saquinavir, Lamivudine, Stavudine
Keywords: Kidney Failure, Chronic, HIV-1, Drug Therapy, Combination, Stavudine, HIV Protease Inhibitors, Lamivudine, Saquinavir, AIDS-Associated Nephropathy, Reverse Transcriptase Inhibitors, Viral Load, Nelfinavir
Medical subject headings: HIV Infections, AIDS-Associated Nephropathy, Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nelfinavir mesylateDrug
SaquinavirDrug
LamivudineDrug
StavudineDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

First posted31 Aug 2001 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Masking: None (open label)
Enrolment: 24 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00002397
Sponsor's protocol ID: 229P
Other IDs: NR15690/M61021
Status last verified: Dec 1998
First submitted: 2 Nov 1999
Last updated: 24 Jun 2005
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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