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Sponsored by: |
Hoffmann-La Roche |
Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002162 |
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 |
MedlinePlus related topics: | AIDS |
ChemIDplus related topics: | Zidovudine Lamivudine Didanosine Stavudine Zalcitabine Saquinavir Saquinavir mesylate |
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.
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:
Show 27 Study Locations |
Hoffmann-La Roche |
Cadman J. Roche brings new formulation of saquinavir to FDA. Food and Drug Administration. GMHC Treat Issues. 1997 Apr-May;11(4/5):8. No abstract available.
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Thompson M. Activity of soft gelatin capsule formulation of saquinavir in combination with two nucleosides in treatment-naive HIV-1-seropositive persons. The NV15355 Study Team. Int Conf AIDS. 1998;12:40 (abstract no 12145)
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Mitsuyasu RT, Skolnik PR, Cohen SR, Conway B, Gill MJ, Jensen PC, Pulvirenti JJ, Slater LN, Schooley RT, Thompson MA, Torres RA, Tsoukas CM. Activity of the soft gelatin formulation of saquinavir in combination therapy in antiretroviral-naive patients. NV15355 Study Team. AIDS. 1998 Jul 30;12(11):F103-9.
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Study ID Numbers: | 229D, NV15355 |
First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002162 |
Health Authority: | United States: Food and Drug Administration |
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