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Invirase (Saquinavir Mesylate) - Summary



INVIRASE brand of saquinavir mesylate is an inhibitor of the human immunodeficiency virus type 1 (HIV-1) protease.

INVIRASE in combination with ritonavir and other antiretroviral agents is indicated for the treatment of HIV-1 infection in adults (over the age of 16 years).

The following points should be considered when initiating therapy with INVIRASE:

– The twice daily administration of INVIRASE in combination with ritonavir is supported by safety data from the MaxCmin 1 trial

[see Adverse Reactions ]

and pharmacokinetic data

[see Clinical Pharmacology ]

.– The efficacy of INVIRASE with ritonavir has not been compared against the efficacy of antiretroviral regimens currently considered standard of care.– The number of baseline primary protease inhibitor mutations affects the virologic response to INVIRASE/ritonavir.


See all Invirase indications & dosage >>


Published Studies Related to Invirase (Saquinavir)

Bioequivalence study of two oral tablet formulations containing tenofovir disoproxil fumarate in healthy volunteers. [2011]
Tenofovir disoproxil fumarate (TDF, CAS 147127-20-6) is a nucleotide reverse transcriptase inhibitor which is indicated in combination with other antiretroviral agents for the management of HIV-1 infection. The objective of this study was to compare the rate and extent of absorption and to assess the bioequivalence between a new pharmaceutical equivalent tablet formulation containing 300 mg of TDF and the innovator product...

Saquinavir/ritonavir monotherapy as a new nucleoside-sparing maintenance strategy in long-term virologically suppressed HIV-infected patients. [2010.09.01]
BACKGROUND: The high antiviral potency and low toxicity of saquinavir/ritonavir (SQV/r) prompted us to assess a viable strategy in chronic virologically suppressed HIV-infected patients... CONCLUSION: SQV/r as monotherapy has proven to be a valid, safe, and economical option for virologically suppressed HIV-infected patients, especially in those who experience intolerance or toxicity with nucleoside analogs.

Gemini: a noninferiority study of saquinavir/ritonavir versus lopinavir/ritonavir as initial HIV-1 therapy in adults. [2009.04.01]
INTRODUCTION:: Direct comparison of the efficacy and safety of different agents is needed to guide selection of optimal treatment regimens for therapy-naive HIV-1-infected patients... CONCLUSIONS:: In treatment-naive, HIV-1-infected patients, SQV/r treatment was noninferior in virologic suppression at 48 weeks to LPV/r treatment and offered a better triglyceride profile.

Pharmacokinetics and safety of saquinavir/ritonavir and omeprazole in HIV-infected subjects. [2008.06]
We investigated the pharmacokinetics and safety of saquinavir/ritonavir when administered with omeprazole simultaneously and 2 h apart to human immunodeficiency virus (HIV) subjects. Saquinavir/ritonavir 12-h pharmacokinetics was assessed with and without omeprazole 40 mg... In the presence of omeprazole, saquinavir plasma exposure is significantly increased in HIV-infected subjects whether administered simultaneously or 2 h apart.

Long-term efficacy and safety of first-line therapy with once-daily saquinavir/ritonavir. [2008]
BACKGROUND: The aim of this study was to assess the long-term efficacy and safety of first-line treatment with once-daily saquinavir/ritonavir plus two nucleoside reverse transcriptase inhibitors (NRTIs)... CONCLUSION: First-line highly active antiretroviral therapy with once-daily saquinavir/ritonavir plus two NRTIs showed strong antiviral efficacy.

more studies >>

Clinical Trials Related to Invirase (Saquinavir)

Lopinavir Capsules to Kaletra or Invirase Tablets [Completed]
This study will compare the benefit for patients switching from Kaletra to Invirase tablets over remaining on Kaletra (based on randomization), to elicit the lipid benefits inferred in previous studies

Bioequivalence Study of Generic GPO Saquinavir and Norvir Versus Invirase and Norvir [Withdrawn]
The previous two studies of generic GPO saquinavir failed to prove bioequivalence. In this study the bio-equivalence will be investigated in healthy Thai volunteers, to see whether the generic GPO saquinavir shows bioequivalence when boosted with Norvir. If the generic formulation is bioequivalent subsequent studies may follow in HIV-1 positive patients.

Saquinavir/Ritonavir in Single Therapy as Maintenance Treatment [Completed]
Study the efficacy of Saquinavir/Ritonavir when given in single therapy as maintenance therapy, compared to standard HAART therapies.

GEMINI Study - A Study of Saquinavir/Ritonavir in Treatment-Naive Patients With HIV-1 Infection [Completed]
This 2 arm study will evaluate the efficacy, safety and tolerability of saquinavir/ritonavir or lopinavir/ritonavir in combination with emtricitabine/tenofovir in patients with human immunodeficiency virus type 1 (HIV-1) infection who have received no prior HIV treatment. Patients will be randomized to receive either saquinavir/ritonavir 1000/100mg oral (po) twice daily (bid) + emtricitabine/tenofovir 200/300mg po once daily (qd), or lopinavir/ritonavir 400/100mg po bid + emtricitabine/tenofovir 200/300mg po qd. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

A Study of Invirase (Saquinavir)/Ritonavir in HIV-Infected Infants and Children. [Completed]
This single arm study will assess the pharmacokinetics, safety and activity of saquinavir (Invirase hard gel capsules, film coated tablets or opened capsules) boosted by combination with ritonavir, in HIV-1 infected infants and children between the ages of 4 months and 6 years. Patients will commence treatment with saquinavir 50mg/kg bid plus ritonavir 2. 5mg/kg or 3. 0mg/kg (dependent on body weight), and a background antiretroviral regimen. If drug exposures are found to be dissimilar to those previously seen in older children and adults, or are associated with toxicities, subsequent dose adjustments will be made. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

more trials >>

Reports of Suspected Invirase (Saquinavir) Side Effects

Hypospadias (7)Maternal Exposure Timing Unspecified (6)Maternal Exposure During Pregnancy (5)Hepatic Function Abnormal (4)Cardiac Failure (4)Pulmonary Hypertension (3)Infection (3)Palpitations (3)Dizziness (3)Penile Curvature (3)more >>

Page last updated: 2011-12-09

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