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| Sponsored by: |
Hoffmann-La Roche |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002162 |
Purpose
To evaluate the antiviral activity and safety of two formulations of saquinavir in combination with licensed nucleoside antiretroviral drugs.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Saquinavir Drug: Lamivudine Drug: Stavudine Drug: Zidovudine Drug: Zalcitabine Drug: Didanosine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Safety Study |
| Official Title: | A Randomized, Parallel Arm, Comparative, Open Label, Multicenter Study of the Activity and Safety of Two Formulations of Saquinavir in Combination With Other Antiretroviral Drugs |
| Estimated Enrollment: | 140 |
Patients are randomized to receive either hard gel or soft gel capsules of saquinavir in combination with at least one licensed nucleoside antiretroviral. Treatment will continue for 48 weeks. After the first 16 weeks, patients will be given the opportunity to roll over to the saquinavir formulation of choice.
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Prior Medication:
Excluded:
Contacts and Locations
Show 27 Study Locations
More Information
| Study ID Numbers: | 229D, NV15355 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002162 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Drug Therapy, Combination Acquired Immunodeficiency Syndrome AIDS-Related Complex Antiviral Agents Saquinavir |
|
Antimetabolites HIV Protease Inhibitors Sexually Transmitted Diseases, Viral Anti-HIV Agents Stavudine Saquinavir Zalcitabine Acquired Immunodeficiency Syndrome Zidovudine Lamivudine AIDS-Related Complex |
Antiviral Agents Immunologic Deficiency Syndromes Protease Inhibitors Reverse Transcriptase Inhibitors Virus Diseases Didanosine Anti-Retroviral Agents HIV Infections Sexually Transmitted Diseases Retroviridae Infections |
|
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Saquinavir Zidovudine Lamivudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections Nucleic Acid Synthesis Inhibitors HIV Protease Inhibitors |
RNA Virus Infections Anti-HIV Agents Immune System Diseases Zalcitabine Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors Virus Diseases Didanosine HIV Infections Sexually Transmitted Diseases Lentivirus Infections |