CLINICAL TRIALS PROFILE FOR SAQUINAVIR
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All Clinical Trials for saquinavir
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00000848 ↗ | The Anti-HIV Effects of Saquinavir Soft Gelatin Capsules Versus Indinavir in Patients Who Have Used Saquinavir Hard Gelatin Capsules for One Year | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | Phase 2 | 1969-12-31 | To determine, in HIV-infected patients, whether switching to a new soft gelatin capsule formulation of saquinavir or to indinavir following prolonged use of the original hard capsule formulation of saquinavir results in an acute decrease in plasma HIV RNA. Resistance to anti-HIV agents occurs with increasing duration of use. In vitro studies have shown that cross-resistance occurs among protease inhibitors, although no clinical trials have been conducted to examine antiretroviral activity with sequential use of protease inhibitors or to determine whether saquinavir resistance can be overcome with higher concentrations of the drug. |
| NCT00000891 ↗ | Immunologic and Virologic Consequences of Long-Term Highly Active Antiretroviral Therapy (HAART) in Subjects With Moderately Advanced HIV-1 Disease: A Follow-Up Study to ACTG 315 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | Phase 2 | 1969-12-31 | To evaluate the relationship between viral suppression and changes in immune function, as measured by the restoration of delayed-type hypersensitivity (DTH) and lymphoproliferative (LP) responses, observed after 48 weeks of treatment with highly active antiretroviral therapy (HAART) in ACTG 315. To evaluate the durability of the antiviral and immunologic effects of long-term treatment with HAART. Given the extensive immunologic and virologic data available from ACTG 315, follow-up studies of this advanced-disease population are indicated to primarily ascertain the impact of long-term suppression of viral replication on immunologic reconstitution or re-education and the durability of the antiviral effects of HAART. |
| NCT00000892 ↗ | A Study of Several Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Used Indinavir | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | N/A | 1969-12-31 | To compare the proportion of patients whose plasma HIV-1 RNA is below 500 copies/ml after 16 weeks of treatment. To assess the safety, toxicity, and tolerance of each treatment arm. While indinavir is currently the most commonly prescribed protease inhibitor, the optimal therapy for a person on an indinavir-containing regimen who experiences a rebound in viral load or never experiences a decrease in viral load below 500 copies per milliliter is unknown. Current clinical practice for such patients typically involves empiric use of a combination of other protease inhibitors (saquinavir/nelfinavir or saquinavir/ritonavir) and at least 1 other antiretroviral agent to which the patient has had little or no prior exposure. This may involve the use of 1 or more reverse transcriptase inhibitors (RTIs) or nonnucleoside reverse transcriptase inhibitors (NNRTIs). This study attempts to formally evaluate some of these options in indinavir-experienced patients. |
| NCT00000898 ↗ | The Effects of Staggered Dosing on Interactions Between Paired Combinations of Nelfinavir, Ritonavir, and Saquinavir | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | N/A | 1969-12-31 | The purpose of this study is to see if staggering doses of nelfinavir, ritonavir, and saquinavir has any effect on the interactions between these drugs. |
| NCT00000906 ↗ | Interactions of HIV Protease Inhibitors and Methadone in HIV-Infected Patients | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | Phase 1 | 1969-12-31 | The purpose of this study is to see if it is safe to combine methadone with two HIV protease inhibitors (PIs), ritonavir (RTV) and saquinavir (SQV), in HIV-infected patients not currently taking PIs. This study will measure the interactions between methadone and the PIs. Methadone is used treat addicts and to treat severe pain. In order to find the safest way to use methadone with PIs, it is important to evaluate how they interact. |
| NCT00000912 ↗ | A Study on Amprenavir in Combination With Other Anti-HIV Drugs in HIV-Positive Patients | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | Phase 2 | 1969-12-31 | The purpose of this study is to compare 4 different combinations of anti-HIV drugs and to determine the number of people whose HIV blood levels decrease to 200 copies/ml or less while on the treatment. This study evaluates the safety of these drug combinations, which include an experimental protease inhibitor (PI), amprenavir. Despite the success that many patients have had with PI treatment regimens, there is still a possibility that patients receiving PIs may continue to have high HIV blood levels. Because of this possibility, alternative drug combinations containing PIs are being studied. It appears that amprenavir, when taken with 3 or 4 other anti-HIV drugs, may be effective in patients with prior PI treatment experience. |
| NCT00000913 ↗ | A Study to Compare Two Anti-HIV Combination Therapies Each Containing Saquinavir in HIV-Positive Children | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | Phase 2 | 1969-12-31 | The purpose of this study is to determine the safety and effectiveness of a soft-gel capsule formulation of saquinavir (SQV-SGC), a protease inhibitor, when given in combination with other anti-HIV drugs. SQV-SGC has been tested in adults for the treatment of HIV infection, but more information is still needed about SQV-SGC in children. Recent studies suggest that this soft-gel capsule form may be safer and more effective than other protease inhibitors. |
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