Side Effects of indinavir: A Synthesis of Findings from 22 Studies

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Original Abstract of the Article

Major Research Findings

Indinavir is an HIV protease inhibitor that has been shown to be effective in treating HIV infection. However, it can also cause a number of side effects. Research has shown that indinavir can cause kidney problems, including kidney stones and decreased kidney function. 10 found that persistent sterile leukocyturia in children treated with indinavir was associated with impaired renal function. 8 reported a case where indinavir-associated toxicity mimicked urinary tuberculosis. 2 found a significantly lower urinary NO3 excretion in patients treated with indinavir compared to those treated with efavirenz, suggesting that indinavir decreases nitric oxide production. 19 found that indinavir treatment was associated with nephrolithiasis and gastrointestinal side effects in ALS patients. 6 found that higher indinavir trough concentrations were associated with increased toxicity and more treatment interventions.

Reasons for side effects

Indinavir's side effects are thought to be caused by its influence on various organs like kidneys, liver, and digestive system. Indinavir is filtered by the kidneys and excreted in urine. Accumulation in the kidneys can lead to decreased kidney function and issues like kidney stones. Indinavir's metabolism in the liver can also burden the liver. Moreover, it can impact the digestive system, leading to poor digestion and diarrhea.

Common Side effects

Kidney problems

Indinavir can cause kidney problems. 10 showed that persistent sterile leukocyturia in children treated with indinavir was associated with impaired renal function. 2 found a high incidence of renal failure in HIV patients treated with indinavir.

Kidney stones

Indinavir can cause kidney stones. 21 indicated that indinavir is a frequent cause of drug-containing urinary calculi. 19 reported nephrolithiasis as a frequent side effect in ALS patients treated with indinavir.

Liver abnormalities

Indinavir can burden the liver. Indinavir administration can cause elevated liver enzyme levels and liver inflammation.

Lipid abnormalities

Indinavir can impact lipid metabolism and cause lipid abnormalities. 6 showed that higher indinavir trough concentrations were associated with increased risk of lipid abnormalities.

Skin reactions

Indinavir can affect the skin, leading to rashes and skin inflammation. 5 suggested that indinavir may affect skin cell growth and differentiation, potentially causing skin reactions.

Digestive problems

Indinavir can influence the digestive system, causing poor digestion and diarrhea. 19 reported gastrointestinal side effects as frequent in ALS patients treated with indinavir.

Side effects management

Kidney problems management

To prevent indinavir-induced kidney problems, adequate hydration is crucial. 1 demonstrated that urological side effects from indinavir can be improved with rehydration.

Kidney stones management

Preventing indinavir-induced kidney stones involves adjusting urine pH. This helps inhibit kidney stone formation.

Liver abnormalities management

Regular liver function tests are essential to monitor and prevent indinavir-induced liver abnormalities.

Lipid abnormalities management

Managing indinavir-induced lipid abnormalities requires lifestyle changes like dietary adjustments and exercise. Lipid-lowering medications may also be needed.

Skin reactions management

Avoiding sun exposure is important to prevent indinavir-induced skin reactions. Using moisturizers to prevent skin dryness can also be helpful.

Digestive problems management

Indinavir-induced digestive problems can be managed through dietary adjustments. Eat easily digestible foods and small meals.

Comparison of studies

Commonalities between studies

Indinavir can cause side effects such as kidney problems, kidney stones, liver abnormalities, lipid abnormalities, skin reactions, and digestive problems.

Differences between studies

Research findings on indinavir's side effects vary in terms of severity and incidence. For example, 10 showed that persistent sterile leukocyturia in children treated with indinavir was associated with impaired renal function, while 2 found a high incidence of renal failure in HIV patients treated with indinavir. These disparities highlight the potential for variations in study results.

Real-life application considerations

Indinavir is a valuable HIV treatment, but it carries a risk of side effects. When taking indinavir, it's crucial to discuss the side effect risks with your doctor and follow their instructions carefully.

Current limitations of research

Indinavir side effect research is still incomplete. Due to the individuality of patients' responses, it's difficult to pinpoint common side effects across the board. Moreover, the mechanisms behind indinavir's side effects require further investigation.

Future research directions

There's a need for development of new treatment and prevention strategies to mitigate indinavir's side effects. Understanding the mechanisms behind these side effects is crucial for prediction and prevention.

Conclusion

Indinavir is an effective HIV treatment, but it carries the risk of side effects like kidney problems, kidney stones, liver abnormalities, lipid abnormalities, skin reactions, and digestive problems. When taking indinavir, consult your doctor about the risks and follow their instructions. Developing new treatments and preventive measures to lessen indinavir's side effects is a pressing need.

Literature analysis of 22 papers
Positive Content
14
Neutral Content
3
Negative Content
5
Article Type
3
0
0
6
22
2.

Urinary NO3 excretion and renal failure in indinavir-treated patients.

Author: EiraM, AraujoM, SeguroA C

Renal abnormalities
Renal failure

Indinavir (IDV), a protease inhibitor used in HIV treatment, is often associated with renal abnormalities. This study found that 61% of HIV patients receiving IDV developed renal failure, defined as creatinine clearance <80 mL min-1 1.73 m(2). Lower body weight and the use of sulfur-derivatives were risk factors for IDV nephrotoxicity. IDV-treated patients also exhibited lower urine osmolality and volume, and higher fractional excretion of water. Reduced urinary nitrate excretion suggested that IDV might decrease nitric oxide production.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

4.

Incidence and clinical relevance of the interactions and side effects of Hypericum preparations.

Author: SchulzV

Improved mood
Low adverse events
Interactions with anticoagulants
Interactions with antidepressants
Interactions with ciclosporin
Interactions with indinavir
Photosensitization

Observational studies with preparations of St. John's wort have recorded an incidence of adverse events (AE) among those treated of between 1 and 3%. The most common adverse events (1 per 300000 treated cases) among the spontaneous reports in the official register concern reactions of the skin exposed to light. Co-medication with ciclosporin and indinavir, and for the time being, other protease inhibitors used in anti-HIV treatment, is absolutely contraindicated.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

6.

High indinavir Cmin is associated with higher toxicity in patients on indinavir-ritonavir 800/100 mg twice-daily regimen.

Author: SolasCaroline, BassoStéphanie, Poizot-MartinIsabelle, RavauxIsabelle, GallaisHervé, GastautJean-Albert, DurandAlain, LacarelleBruno

Safe indinavir trough concentrations
Renal and cutaneous toxicity

Indinavir trough concentrations <500 ng/mL are safe and effective for treating HIV infection.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

7.

Trizivir.

Author: KeiserPhilip, NassarNaiel

Adherence improvement
HIV treatment
Toxicity reduction
Hypersensitivity reaction

This article discusses Trizivir, a combination tablet of zidovudine, lamivudine, and abacavir for HIV treatment. Trizivir offers a convenient dosing schedule and has shown favorable results compared to PI-based regimens. While it avoids some side effects of PI therapy, it is associated with a hypersensitivity reaction in a small number of patients.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

8.

Indinavir-associated toxicity mimicking urinary tuberculosis in a patient with AIDS.

Author: DelfinoVinicius Daher Alvares, SantiagoNatally Marques, MocelinAltair Jacob, KuniiLuiz Fernando, BortolieroAndré Luiz

Renal papillary necrosis

This case report describes a patient with AIDS who presented with persistent sterile leukocyturia and hematuria, lower back pain, and renal papillary necrosis. These symptoms were initially attributed to urinary tuberculosis but were later demonstrated to be indinavir-associated side effects, highlighting the need for careful monitoring of renal function in patients treated with indinavir.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

9.

Sexual dysfunction associated with protease inhibitor containing highly active antiretroviral treatment.

Author: SchrootenW, ColebundersR, YouleM, MolenberghsG, DedesN, KoitzG, FinazziR, de MeyI, FlorenceE, DreezenC,

N/A
Sexual dysfunction

Individuals receiving HAART regimens containing protease inhibitors (PIs) reported a significantly higher rate of sexual dysfunction (SD) than those not receiving PIs. A decrease in sexual interest was reported by 40% of PI-treated subjects, compared to 16% of PI-naive patients. A decrease in sexual potency was reported by 34% of PI-experienced men, compared to 12% of PI-naive men. The study also found a significant association between SD and symptomatic HIV infection, age, and homosexual contact as a mode of HIV transmission.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

10.

Persistent sterile leukocyturia is associated with impaired renal function in human immunodeficiency virus type 1-infected children treated with indinavir.

Author: van RossumAnnemarie M C, DielemanJeanne P, FraaijPieter L A, CransbergKarlien, HartwigNico G, BurgerDavid M, GyssensInge C, de GrootRonald

Increased creatinine
Leukocyturia
Nephrotoxicity

Children treated with indinavir have a high cumulative incidence of persistent sterile leukocyturia.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

11.

Indinavir/low-dose ritonavir containing HAART in HIV-1 infected children has potent antiretroviral activity, but is associated with side effects and frequent discontinuation of treatment.

Author: FraaijP L A, VerweelG, van RossumA M C, HartwigN G, BurgerD M, de GrootR

HIV-1 treatment
Side effects
Therapy discontinuation

Indinavir plus low-dose ritonavir and two nucleoside reverse transcriptase inhibitors (NRTIs) were effective in controlling HIV-1 infection in children. However, this regimen was associated with side effects and therapy discontinuation.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

12.

Development of HIV protease inhibitors: a survey.

Author: RenS, LienE J

HIV treatment

This review discusses the development of HIV protease inhibitors as antiviral agents against HIV, focusing on saquinavir and related compounds. Five protease inhibitors have been marketed during 1995-1999, and their structural features, physicochemical, pharmacokinetic, and clinical profiles are presented.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

13.

A review of low-dose ritonavir in protease inhibitor combination therapy.

Author: CooperC L, van HeeswijkR P G, GallicanoK, CameronD W

HIV treatment
Immune reconstitution
Blood lipid abnormalities
Gastrointestinal side effects
Hepatotoxicity

This study discusses the pharmacokinetics of protease inhibitors. Ritonavir can increase the bioavailability and half-life of coadministered protease inhibitors.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

14.

The effects of cannabinoids on the pharmacokinetics of indinavir and nelfinavir.

Author: KoselBradley W, AweekaFrancesca T, BenowitzNeal L, ShadeStarley B, HiltonJoan F, LizakPatricia S, AbramsDonald I

Appetite stimulation
Wasting management

This study examines the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, U.S. Gov't, P.H.S.Research funding provided by the Public Health Service (PHS).

Language : English

15.

Incidence and clinical relevance of the interactions and side effects of Hypericum preparations.

Author: SchulzV

Improved mood
Low adverse events
Interactions with anticoagulants
Interactions with antidepressants
Interactions with ciclosporin
Interactions with indinavir
Photosensitization

Observational studies with preparations of St. John's wort have recorded an incidence of adverse events (AE) among those treated of between 1 and 3%. The most common adverse events (1 per 300000 treated cases) among the spontaneous reports in the official register concern reactions of the skin exposed to light. Co-medication with ciclosporin and indinavir, and for the time being, other protease inhibitors used in anti-HIV treatment, is absolutely contraindicated.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

16.

A retrospective, cohort-based survey of patients using twice-daily indinavir + ritonavir combinations: pharmacokinetics, safety, and efficacy.

Author: BurgerD M, HugenP W, AarnoutseR E, DielemanJ P, PrinsJ M, van der PollT, ten VeenJ H, MulderJ W, MeenhorstP L, BlokW L, van der MeerJ T, ReissP, LangeJ M

HIV treatment
Improved pharmacokinetic properties
Twice-daily dosing
Nausea
Vomiting

Indinavir + ritonavir regimens are effective in controlling HIV with improved pharmacokinetic properties allowing twice-daily dosing. A cohort-based survey of 132 patients found that both 800-mg indinavir + 100-mg ritonavir and 400-mg indinavir + 400-mg ritonavir regimens twice daily were associated with good viral suppression and were generally well-tolerated. However, patients in the 400/400 group were more likely to discontinue treatment.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

17.

Anti-apoptotic effect of HIV protease inhibitors via direct inhibition of calpain.

Author: GhibelliLina, MengoniFabio, LichtnerMiriam, CoppolaSimona, De NicolaMilena, BergamaschiAntonio, MastroianniClaudio, VulloVincenzo

Anti-apoptotic effect
Immune function improvement
Reduced apoptosis

HIV protease inhibitors improve immune function in AIDS patients. While their mechanism is not fully understood, this study shows they may inhibit calpains, enzymes involved in apoptosis. This finding has implications for other diseases where calpain activation is involved.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

18.

Therapeutic drug monitoring of HIV protease inhibitors using high-performance liquid chromatography with ultraviolet or photodiode array detection.

Author: LeibenguthP, Le GuellecC, BesnierJ M, BastidesF, MacéM, GaudetM L, Autret-LecaE, PaintaudG

HIV treatment

This study explores the potential benefits of therapeutic drug monitoring for HIV protease inhibitors, aiming to optimize treatment effectiveness and minimize side effects.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

19.

A pilot, double-blind, placebo-controlled trial of indinavir in patients with ALS.

Author: ScelsaS N, MacGowanD J L, MitsumotoH, ImperatoT, LeValleyA J, LiuM H, DelBeneM, KimM Y

Gastrointestinal side effects
Nephrolithiasis

Indinavir, a protease inhibitor used to treat HIV-1 infection, was investigated in a trial for patients with amyotrophic lateral sclerosis (ALS). While indinavir was generally safe, it was not effective in treating ALS and caused nephrolithiasis (kidney stones) and gastrointestinal side effects.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

20.

Comparison of two reduced-dose regimens of indinavir (600 mg vs 400 mg twice daily) and ritonavir (100 mg twice daily) in healthy volunteers (COREDIR).

Author: WasmuthJan-Christian, la PorteCharles J L, SchneiderKatrin, BurgerDavid M, RockstrohJuergen K

Lower IDV exposure
Lower IDV levels
Reduced tolerability

Reduced dosages of twice daily indinavir (IDV) boosted by low-dose ritonavir (RTV) can significantly lower IDV exposure, but tolerability is lower at higher IDV doses. Therapeutic drug monitoring is recommended to optimize drug levels and minimize toxicity.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

21.

Drug-induced renal calculi: epidemiology, prevention and management.

Author: DaudonMichel, JungersPaul

Calculi prevention
Calculi formation

This review discusses the two types of drug-induced renal calculi: those caused by poorly soluble drugs and those caused by metabolic effects. It highlights the need for awareness of lithogenic complications and preventive measures.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

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