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Ritonavir and Agenerase Treatment for Patients Who Have Failed Previous Anti-HIV Treatment

The Safety and Efficacy of a Ritonavir-Enhanced Agenerase Regimen as Salvage Therapy in HIV-Infected Individuals

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00006591
Enrollment
Unknown
Registered
2001-08-31
Start date
Unknown
Completion date
Unknown
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Drug Therapy, Combination, HIV Protease Inhibitors, Ritonavir, VX 478, Salvage Therapy, Anti-HIV Agents, Drug Monitoring, Nelfinavir, Treatment Experienced

Brief summary

The purpose of this study is to determine if treatment with an anti-HIV drug containing ritonavir and Agenerase is safe and can lower the level of HIV in the blood in patients who have failed an anti-HIV drug treatment containing nelfinavir.

Detailed description

HIV-infected patients will be treated with a ritonavir-enhanced Agenerase regimen.

Interventions

DRUGRitonavir
DRUGAmprenavir

Sponsors

Gathe, Joseph, M.D.
Lead SponsorINDIV

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients may be eligible for this study if they: * Are 18 years of age or older. * Are HIV-positive. * Have a viral load (level of HIV in the body) of more than 1,000 copies/ml. * Have had more than 12 weeks of prior anti-HIV drug treatment. * Have failed a previous anti-HIV treatment containing nelfinavir as the only protease inhibitor. * Are responsive to Agenerase. * Are able to follow study requirements.

Exclusion criteria

Patients will not be eligible for this study if they: * Are intolerant to ritonavir (an anti-HIV drug). * Have or have had problems with absorption. * Have liver disease or damage. * Have pancreatic disease or damage. * Have taken any protease inhibitor other than nelfinavir. * Are receiving investigational drugs or devices from another study. * Are pregnant or breast-feeding. * Currently use triazolam, astemizole, ergot medications, cisapride, midazolam, bepridil, rifampin, terfenadine, or pimozide. * Have a bleeding disorder. * Have previously been treated with Agenerase. * Are receiving nonnucleosides.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026