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A Study of Saquinavir Soft Gelatin Capsules Combined With Other Anti-HIV Drugs in HIV-1 Infected Patients

NCT ID: NCT00002374

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Brief Summary

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To examine the efficacy of saquinavir SGC (soft gel capsules) in combination with other antiretrovirals in HIV-1 infected patients currently treated with saquinavir HGC (hard gel capsules) measured by the absolute change in plasma HIV-1 RNA during the 24 weeks of study treatment.

Detailed Description

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Eligible patients will be stratified by HIV-1 RNA level into 2 populations: 1) \>= 5,000-30,000 HIV-1 RNA, 2) \> 30,000 HIV-1 RNA. All patients will be randomized to 1 of 3 treatment arms: Arm A - Saquinavir soft gel capsules (SQV SGC) + 2 new nucleoside analogs (reverse transcriptase inhibitors \[RTIs\]), Arm B - SQV SGC + nelfinavir + stavudine (d4T) or a new RTI, or Arm C - SQV SGC + ritonavir + d4T or a new RTI. All patients will undergo plasma HIV-1 RNA determinations, CD4 lymphocyte counts, hematology and chemistry blood work at baseline, weeks 4, 8, 12, 16 and 24.

Conditions

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HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Ritonavir

Intervention Type DRUG

Nelfinavir mesylate

Intervention Type DRUG

Saquinavir

Intervention Type DRUG

Stavudine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients must have:

* Documented HIV infection.
* CD4 \> 100 cells/mm3.
* Saquinavir HGC-experienced patients (\>= 3 months cumulative therapy).

Required:

\>= 3 months cumulative saquinavir HGC therapy.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Locations

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Pacific Oaks Med Ctr

Beverly Hills, California, United States

Site Status

Tower Infectious Diseases / Med Associates Inc

Los Angeles, California, United States

Site Status

Community Research Initiative of South Florida

Coral Gables, Florida, United States

Site Status

Ctr for Quality Care

Tampa, Florida, United States

Site Status

Community Research Initiative of New England

Brookline, Massachusetts, United States

Site Status

AIDS Ctr

New York, New York, United States

Site Status

Anderson Clinical Research / Inc

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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Cadman J. Roche brings new formulation of saquinavir to FDA. Food and Drug Administration. GMHC Treat Issues. 1997 Apr-May;11(4/5):8.

Reference Type BACKGROUND
PMID: 11364377 (View on PubMed)

Other Identifiers

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NR15521

Identifier Type: -

Identifier Source: secondary_id

229G

Identifier Type: -

Identifier Source: org_study_id