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Antiretroviral medications+Isoniazid prophylaxis
Antiretroviral medications+Isoniazid prophylaxis is a Antiretroviral combination therapy + antimycobacterial prophylaxis Small molecule drug developed by French National Agency for Research on AIDS and Viral Hepatitis. It is currently in Phase 3 development for HIV infection with tuberculosis co-infection or latent TB infection requiring prophylaxis, Prevention of tuberculosis in HIV-positive patients.
This combination uses antiretroviral drugs to suppress HIV replication while isoniazid prophylaxis prevents tuberculosis infection in co-infected patients.
This combination uses antiretroviral drugs to suppress HIV replication while isoniazid prophylaxis prevents tuberculosis infection in co-infected patients. Used for HIV infection with tuberculosis co-infection or latent TB infection requiring prophylaxis, Prevention of tuberculosis in HIV-positive patients.
At a glance
| Generic name | Antiretroviral medications+Isoniazid prophylaxis |
|---|---|
| Sponsor | French National Agency for Research on AIDS and Viral Hepatitis |
| Drug class | Antiretroviral combination therapy + antimycobacterial prophylaxis |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | Phase 3 |
Mechanism of action
Antiretroviral medications (typically including nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, protease inhibitors, or integrase inhibitors) block HIV replication at multiple steps of the viral lifecycle. Isoniazid is a prodrug that inhibits mycobacterial cell wall synthesis, providing prophylactic protection against tuberculosis (TB) in HIV-positive individuals at risk of TB co-infection or with latent TB infection.
Approved indications
- HIV infection with tuberculosis co-infection or latent TB infection requiring prophylaxis
- Prevention of tuberculosis in HIV-positive patients
Common side effects
- Peripheral neuropathy (isoniazid-related)
- Hepatotoxicity
- Gastrointestinal disturbances
- Rash
- Drug interactions
Key clinical trials
- An Adaptive Multi-arm Trial to Improve Clinical Outcomes Among Children Recovering From Complicated SAM (PHASE3)
- Rifapentine and Isoniazid TB Preventive Therapy (3HP) for Children Taking Dolutegravir-based Antiretroviral Treatment (DOLPHIN KIDS) (PHASE1, PHASE2)
- Safety Tolerability DDI Short Course Treatment of LTBI Infection With High-dose Rifapentine and Isoniazid or Standard Isoniazid Preventive Therapy in HIV+ Patients (DOLPHIN & DOLPHIN TOO) (PHASE1, PHASE2)
- IMPAACT P1106: Pharmacokinetic Characteristics of Antiretrovirals and Tuberculosis Medicines in Low Birth Weight Infants
- Package of Care to Improve Retention in ART and Mortality Among Treatment Naive HIV Infected Individuals (PHASE4)
- Early Antiretroviral Treatment and/or Early Isoniazid Prophylaxis Against Tuberculosis in HIV-infected Adults (ANRS 12136 TEMPRANO) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Antiretroviral medications+Isoniazid prophylaxis CI brief — competitive landscape report
- Antiretroviral medications+Isoniazid prophylaxis updates RSS · CI watch RSS
- French National Agency for Research on AIDS and Viral Hepatitis portfolio CI
Frequently asked questions about Antiretroviral medications+Isoniazid prophylaxis
What is Antiretroviral medications+Isoniazid prophylaxis?
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Related
- Drug class: All Antiretroviral combination therapy + antimycobacterial prophylaxis drugs
- Manufacturer: French National Agency for Research on AIDS and Viral Hepatitis — full pipeline
- Therapeutic area: All drugs in Infectious Disease / Virology
- Indication: Drugs for HIV infection with tuberculosis co-infection or latent TB infection requiring prophylaxis
- Indication: Drugs for Prevention of tuberculosis in HIV-positive patients
- Compare: Antiretroviral medications+Isoniazid prophylaxis vs similar drugs
- Pricing: Antiretroviral medications+Isoniazid prophylaxis cost, discount & access