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| Sponsored by: |
Hoffmann-La Roche |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002397 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections AIDS-Associated Nephropathy |
Drug: Nelfinavir mesylate Drug: Saquinavir Drug: Lamivudine Drug: Stavudine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Safety 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 |
| Estimated Enrollment: | 24 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Prior Medication:
Excluded:
Required:
Stable antiretroviral therapy for more than 4 weeks.
Contacts and Locations More Information
| Study ID Numbers: | 229P, NR15690/M61021 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002397 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Kidney Failure, Chronic HIV-1 Drug Therapy, Combination Stavudine HIV Protease Inhibitors Lamivudine |
Saquinavir AIDS-Associated Nephropathy Reverse Transcriptase Inhibitors Viral Load Nelfinavir |
|
Antimetabolites Anti-Infective Agents AIDS-Associated Nephropathy HIV Protease Inhibitors Sexually Transmitted Diseases, Viral Anti-HIV Agents Stavudine Saquinavir Acquired Immunodeficiency Syndrome Kidney Failure, Chronic Lamivudine Antiviral Agents |
Immunologic Deficiency Syndromes Protease Inhibitors Reverse Transcriptase Inhibitors Virus Diseases Anti-Retroviral Agents Urologic Diseases HIV Infections Sexually Transmitted Diseases Kidney Diseases Nelfinavir Retroviridae Infections Kidney Failure |
|
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Stavudine Molecular Mechanisms of Pharmacological Action Saquinavir Lamivudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Urologic Diseases Therapeutic Uses Kidney Diseases Nelfinavir |
Retroviridae Infections Nucleic Acid Synthesis Inhibitors AIDS-Associated Nephropathy HIV Protease Inhibitors RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors Virus Diseases HIV Infections |
