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NCT00000859 · ClinicalTrials.gov registry record · NA
A Randomized Trial of the Efficacy and Safety of a Strategy of Starting With Nelfinavir Versus Ritonavir Added to Background Antiretroviral (AR) Nucleoside Therapy in HIV-Infected Individuals With CD4+ Cell Counts Less Than or Equal to 200/mm3
A NA study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- NA
- Development phase
- 1,300
- Enrollment target
NCT00000859 is a NA study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 1,300 participants.
The verdict
NCT00000859, a NA study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- NA
- Development phase
- 1,300 participants
- Enrollment target
Study Summary
To compare nelfinavir (NFV) with ritonavir (RTV) for delaying disease progression or death in HIV-infected patients with CD4+ cell counts less than 100 cells/mm3 \[AS PER AMENDMENT 3/11/98: less than or equal to 200 cells/mm3\]. To compare NFV with RTV for the development of adverse events and for rates of permanent discontinuation of study medication. \[AS PER AMENDMENT 10/02/97: To compare by intention-to-treat analysis for disease progression, including death, the following two regimens: NFV plus background combination antiretroviral (AR) therapy followed by indinavir (IDV) or RTV in the event of significant intolerance; and RTV plus AR therapy followed by IDV, then NFV, in the event of significant intolerance.\] \[AS PER AMENDMENT 3/11/98: SUBSTUDY CPCRA 045: To determine the relative rates of emergence of HIV-1 resistance and to compare changes in plasma HIV RNA levels and CD4+ cell counts in a sample of patients with CD4+ cell counts \<= 200/mm3 who are enrolled in protocol CPCRA 042.\] AR therapy is rapidly becoming the standard of care for the treatment of HIV infection. AR therapy provides the best opportunity for maximizing viral suppression, reducing toxicity and delaying the emergence of resistant strains. The newest class of AR agents, the HIV protease inhibitors, exhibits the most potent anti-HIV effects described to date. This study will compare 2 protease inhibitors, NFV and RTV for efficacy and safety in a population with advanced HIV disease, who are taking various background nucleoside therapies.
Interventions
- DRUG Ritonavir
- DRUG Indinavir sulfate
- DRUG Nelfinavir mesylate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,300 participants |
| Est. Completion | 2001-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000859
The ClinicalTrials.gov registry entry for NCT00000859 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 1,300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Ritonavir is the first listed.
NCT00000859 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00000859 about?
NCT00000859 is a clinical study titled "A Randomized Trial of the Efficacy and Safety of a Strategy of Starting With Nelfinavir Versus Ritonavir Added to Background Antiretroviral (AR) Nucleoside Therapy in HIV-Infected Individuals With CD4+ Cell Counts Less Than or Equal to 200/mm3". To compare nelfinavir (NFV) with ritonavir (RTV) for delaying disease progression or death in HIV-infected patients with CD4+ cell counts less than 100 cells/mm3 \[AS PER AMENDMENT 3/11/98: less than or equal to 200 cells/mm3\]. To compare NFV with RTV for the development of adverse events and for r...
What is the current status of trial NCT00000859?
This trial is currently completed. It is a NA study. The enrollment target is 1,300 participants. Estimated completion is 2001-12.
What interventions are being tested in trial NCT00000859?
The interventions under investigation include: Ritonavir (DRUG), Indinavir sulfate (DRUG), Nelfinavir mesylate (DRUG).
Who is sponsoring clinical trial NCT00000859?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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