A Study of Saquinavir Soft Gel Capsules (SGC) Used in Combination With Two Other Anti-HIV Drugs in Patients With HIV-Associated Kidney Disease
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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 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Masking: Open Label Primary Purpose: Treatment |
| 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:
- Detectable HIV-1 RNA by Amplicor assay.
- Biopsy-proven nephropathy.
Exclusion Criteria
Prior Medication:
Excluded:
- Saquinavir and nelfinavir.
- d4T or 3TC within the past 4 months.
Required:
Stable antiretroviral therapy for more than 4 weeks.
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00002397 History of Changes |
| Other Study ID Numbers: | 229P, NR15690/M61021 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
|
Kidney Failure, Chronic HIV-1 Drug Therapy, Combination Stavudine HIV Protease Inhibitors Lamivudine |
Saquinavir AIDS-Associated Nephropathy Reverse Transcriptase Inhibitors Viral Load Nelfinavir |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections Kidney Diseases AIDS-Associated Nephropathy Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases Urologic Diseases HIV Protease Inhibitors |
Saquinavir Nelfinavir Stavudine Lamivudine Reverse Transcriptase Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Antimetabolites |
ClinicalTrials.gov processed this record on May 21, 2013