Indinavir

Evidence Level: L4

Predicted Indications: 5

Indinavir

Pharmacist Assessment Report

Indinavir: From HIV Infection to Simian Immunodeficiency Virus Infection

One-Sentence Summary

Indinavir is an HIV-1 protease inhibitor, originally used to treat HIV infection and AIDS. The TxGNN model predicts it may be effective for simian immunodeficiency virus infection, but the supporting evidence is limited to 0 clinical trials and 8 preclinical or animal-model publications, with no human clinical relevance.

Quick Overview

Item	Content
Original Indication	HIV infection / AIDS
Predicted New Indication	Simian immunodeficiency virus infection
TxGNN Prediction Score	0.9999
Evidence Level	L4
India Market Status	Listed in a compiled Indian medicine price dataset (2 of 2) – CDSCO approval status is not included in this data
Number of Listed Products	2 (valid: 2)
Recommended Decision	Hold

Why is This Prediction Reasonable?

Currently, detailed mechanism of action data is not available. Based on known information, indinavir is an HIV-1 protease inhibitor. Its efficacy in HIV infection has been established, and mechanistically it may be applicable to simian immunodeficiency virus (SIV), a closely related lentivirus.

In vitro studies support this link. In one study, indinavir inhibited SIVmac239 with a 50% effective concentration of about 39 nM, compared with about 66 nM for HIV-1. Macaque studies also used indinavir as part of combination antiretroviral regimens.

However, SIV does not infect humans. The value of this prediction is as a research model for HIV, not as a new therapeutic indication for patients. Other predictions in the list are more relevant to human care but largely overlap with the original indication. These include congenital HIV (a perinatal and pediatric population) and AIDS-related complex (a historical term for symptomatic HIV disease).

Clinical Trial Evidence

Currently no related clinical trials registered for simian immunodeficiency virus infection.

For reference, the following trials relate to HIV-related predictions and are population subsets of the original indication, not evidence for the SIV prediction:

Trial Number	Phase	Status	Enrollment	Key Findings
NCT00002354	Not specified	Completed	540	Indinavir plus stavudine in AZT-experienced HIV-positive patients, one-year safety and efficacy
NCT00000848	Phase 2	Completed	144	Switching from hard-capsule saquinavir to soft-capsule saquinavir or to indinavir
NCT00002386	Phase 4	Completed	55	Combination therapy including indinavir and its effect on clotting in HIV patients with hemophilia
NCT00002351	Phase 1	Completed	12	Safety, tolerability and pharmacokinetics of indinavir in older children and adolescents with HIV

Literature Evidence

PMID	Year	Type	Journal	Key Findings
19240457	2009	Animal study	AIDS	Post-exposure prophylaxis with zidovudine, lamivudine and indinavir after vaginal exposure in macaques
12709355	2003	In vitro	Antimicrob Agents Chemother	SIVmac239 inhibited by indinavir (about 39 nM), similar to HIV-1 (about 66 nM)
15040537	2004	In vitro	Antivir Ther	Activity of approved anti-HIV drugs against HIV-2, SIV and SHIV, relevant to treatment and post-exposure prophylaxis
14610172	2003	Animal study	J Virol	Effect of early antiviral therapy on lymphocyte proliferation in SIVmac251-infected macaques
15378436	2004	Animal study	J Infect Dis	Tenofovir with or without indinavir and T cell responses in SIV-infected macaques with mycobacterial coinfection
11689641	2001	Animal study	J Virol	Persistent bone marrow hematopoiesis defect in SHIV-infected macaques despite viremia control by HAART
12804006	2003	In vitro mechanistic	AIDS Res Hum Retroviruses	Effects of infection and HAART on P-glycoprotein and cell kinase expression in a primate AIDS model
11364629	1997	Commentary	J Int Assoc Physicians AIDS Care	Commentary on chemokine receptor chimeras

India Market Information

Authorization Number	Product Name	Dosage Form	Approved Indication
112511	Indease 400mg Capsule (Alkem Laboratories Ltd)	Strip of 10 capsules	Not stated in the data compiled
238636	Virodin 400mg Tablet (Sun Pharmaceutical Industries Ltd)	Strip of 10 tablets	Not stated in the data compiled

Safety Considerations

Package insert warnings and contraindications were not available in the data compiled for this report. Please refer to the package insert for safety information.

Disease associations flagged in the knowledge graph (not label text): liver disease, cirrhosis of liver, gallbladder disease, hyperglycemia, diabetes mellitus, diabetic ketoacidosis, hemophilia, hypertriglyceridemia, hyperbilirubinemia (including hereditary forms and Gilbert syndrome), nephrolithiasis, acute urate nephropathy, hemolytic anemia and pyuria. These should be verified against the official label.
Drug Interactions: 229 interactions were recorded. The first 20 retrieved include:
- Major: loperamide, triamcinolone, budesonide
- Moderate: acarbose, rabeprazole, omeprazole, hydrocortisone, dexamethasone, betamethasone, metformin, alogliptin, albiglutide, canagliflozin, chlorpropamide, alosetron, aprepitant
- Minor: ascorbic acid, clarithromycin
The full list should be reviewed before any use.

Conclusion and Next Steps

Decision: Hold

Rationale: The SIV prediction rests only on in vitro and macaque studies, with no human trials. SIV does not infect humans, so this is a research-model finding rather than a viable new indication. Indinavir has been superseded by newer agents. The remaining predictions (feline AIDS, a rare neurodevelopmental disorder, obsolete familial combined hyperlipidemia, fibroma of prostate) have no supporting evidence. Their scores come from the TxGNN model (deep learning) and may reflect similarities the model learned between related diseases, not biological evidence.

To proceed, the following is needed:

Package insert warnings and contraindications from the India regulatory source, which are required for safety screening
Detailed mechanism of action data
Clarification of whether a veterinary or research-model use of indinavir is actually of interest, since no human repurposing case exists for this prediction
Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.