CLINICAL TRIALS PROFILE FOR RIFAMPIN AND ISONIAZID

All Clinical Trials for Rifampin And Isoniazid

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000636 ↗	Prophylaxis Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To evaluate and compare the effectiveness of a 2-month regimen of rifampin and pyrazinamide versus a 1-year course of isoniazid (INH) to prevent the development of tuberculosis in patients who are coinfected with HIV and latent Mycobacterium tuberculosis (MTb). Current guidelines recommend 6 to 12 months of treatment with INH for purified protein derivative (PPD)-positive individuals. Problems with this treatment include compliance, adverse reaction, and the possibility of not preventing disease due to INH-resistant organisms. Studies suggest that two or three months of rifampin and pyrazinamide may be more effective than longer courses of INH. A two-month prevention course should help to increase compliance. In addition, the use of two drugs (rifampin and pyrazinamide) may help overcome problems with drug resistance.
NCT00000638 ↗	Preventive Treatment Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection	Completed	Hoechst Marion Roussel	N/A	1969-12-31	To evaluate and compare the safety and effectiveness of a one-year course of isoniazid (INH) versus a two-month course of rifampin plus pyrazinamide for the prevention of reactivation tuberculosis in individuals infected with both HIV and latent (inactive) Mycobacterium tuberculosis. Current guidelines from the American Thoracic Society and the Centers for Disease Control recommend 6 to 12 months of INH for PPD (purified protein derivative)-positive individuals. Although the effectiveness of this treatment is not known for HIV-infected individuals, several studies using INH to prevent tuberculosis in presumably normal hosts have shown 60 to 80 percent effectiveness. Problems with this treatment include compliance, adverse reaction, and the possibility of not preventing disease due to tuberculosis organisms being resistant to INH. A two-month preventive treatment plan should help in increasing compliance. In addition, the use of two drugs (rifampin / pyrazinamide) may help overcome problems with drug resistance. If this study shows equal or greater effectiveness of the two-month rifampin / pyrazinamide treatment, it could alter the approach to tuberculosis prevention for both HIV-positive and HIV-negative individuals.
NCT00000638 ↗	Preventive Treatment Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection	Completed	Lederle Laboratories	N/A	1969-12-31	To evaluate and compare the safety and effectiveness of a one-year course of isoniazid (INH) versus a two-month course of rifampin plus pyrazinamide for the prevention of reactivation tuberculosis in individuals infected with both HIV and latent (inactive) Mycobacterium tuberculosis. Current guidelines from the American Thoracic Society and the Centers for Disease Control recommend 6 to 12 months of INH for PPD (purified protein derivative)-positive individuals. Although the effectiveness of this treatment is not known for HIV-infected individuals, several studies using INH to prevent tuberculosis in presumably normal hosts have shown 60 to 80 percent effectiveness. Problems with this treatment include compliance, adverse reaction, and the possibility of not preventing disease due to tuberculosis organisms being resistant to INH. A two-month preventive treatment plan should help in increasing compliance. In addition, the use of two drugs (rifampin / pyrazinamide) may help overcome problems with drug resistance. If this study shows equal or greater effectiveness of the two-month rifampin / pyrazinamide treatment, it could alter the approach to tuberculosis prevention for both HIV-positive and HIV-negative individuals.

Clinical Trial Conditions for Rifampin And Isoniazid

Condition Name

Condition Name for Rifampin And Isoniazid
Intervention	Trials
Tuberculosis	28
HIV Infections	8
Tuberculosis, Pulmonary	7

Condition MeSH

Condition MeSH for Rifampin And Isoniazid
Intervention	Trials
Tuberculosis	50
Tuberculosis, Pulmonary	19
Infections	9

Clinical Trial Locations for Rifampin And Isoniazid

Trials by Country

Trials by Country for Rifampin And Isoniazid
Location	Trials
United States	141
China	40
Canada	22
South Africa	19
Brazil	13

Trials by US State

Trials by US State for Rifampin And Isoniazid
Location	Trials
California	13
New York	13
Texas	11
Maryland	9
Illinois	9

Clinical Trial Progress for Rifampin And Isoniazid

Clinical Trial Phase

Clinical Trial Phase for Rifampin And Isoniazid
Clinical Trial Phase	Trials
Phase 4	11
Phase 3	15
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for Rifampin And Isoniazid
Clinical Trial Phase	Trials
Completed	31
Not yet recruiting	6
Recruiting	5

Clinical Trial Sponsors for Rifampin And Isoniazid

Sponsor Name

Sponsor Name for Rifampin And Isoniazid
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	10
Centers for Disease Control and Prevention	10
National Taiwan University Hospital	4

Sponsor Type

Sponsor Type for Rifampin And Isoniazid
Sponsor	Trials
Other	126
U.S. Fed	16
Industry	12

Clinical Trials, Market Analysis, and Projections for Rifampin and Isoniazid

Introduction to Rifampin and Isoniazid

Rifampin and isoniazid are two of the most critical antibiotics used in the treatment of tuberculosis (TB), a bacterial infection that affects millions worldwide. These drugs are cornerstone components of both latent TB infection (LTBI) treatment and active TB treatment regimens.

Clinical Trials and Efficacy

Treatment of Latent Tuberculosis Infection (LTBI)

Clinical trials have consistently shown that rifampin and isoniazid have distinct advantages in treating LTBI.

• Rifampin vs Isoniazid: A retrospective study published in the Archives of Internal Medicine compared the effectiveness and safety of 4 months of rifampin monotherapy with 9 months of isoniazid monotherapy for LTBI. The study found that rifampin was associated with higher treatment completion rates (71.6% vs 52.6%) and lower rates of clinically recognized adverse reactions (1.9% vs 4.6%)[1].
• Short-Course Combination Therapy: Another prospective, randomized study compared 3- and 4-month combination regimens of isoniazid plus rifampin with a 9-month regimen of isoniazid monotherapy. The results indicated that short-course combination therapy was safe and superior to isoniazid monotherapy, with better compliance and fewer radiographic findings suggestive of active disease[4].

Active Tuberculosis Treatment

For active TB, the standard regimen includes a combination of isoniazid, rifampin, pyrazinamide, and ethambutol for the first 6 months, followed by isoniazid and rifampin for an additional 4 months.

• Drug Susceptibility: Studies have identified susceptibility breakpoints for these drugs, which help in tailoring treatment regimens. For instance, higher doses of isoniazid and rifampin can be used to treat strains with intermediate susceptibility, potentially preventing the need for more toxic second-line treatments[3].

Market Analysis

Market Size and Growth

The anti-tuberculosis therapeutics market is expected to grow significantly over the forecast period.

• Global Market: The global tuberculosis drugs market is projected to grow from USD 1,622.15 million in 2020 to USD 2,095.09 million by 2025, driven by increasing initiatives for TB awareness and rising healthcare spending[5].
• Segment Growth: The isoniazid segment is anticipated to register a high CAGR due to its widespread use in TB treatment and the introduction of new treatment regimens, such as the fixed-dose combination of rifapentine and isoniazid, which reduces the pill burden[2].

Market Drivers

Several factors are driving the growth of the anti-tuberculosis therapeutics market:

• Rising Prevalence of Tuberculosis: The increasing incidence of TB, particularly in emerging economies, is a significant driver.
• Government Initiatives: Growing initiatives from government organizations for TB awareness and treatment are boosting market growth.
• Rising Incidence of MDR and XDR TB: The increasing cases of multi-drug resistant (MDR) and extensively drug-resistant (XDR) TB are necessitating the development of more effective and safe drugs[2].

Market Restraints

Despite the growth, there are several challenges:

• Adverse Side Effects: Anti-tuberculosis drugs, including isoniazid and rifampin, can have adverse side effects, which can lead to treatment discontinuation.
• High Cost of MDR and XDR TB Drugs: The high cost of treating MDR and XDR TB is a significant restraint, particularly in low-income countries[2].

Market Projections

Forecast Period

The market for anti-tuberculosis therapeutics, including rifampin and isoniazid, is expected to grow at a CAGR of 6.2% by 2027.

• Increasing Adoption: The increasing adoption of isoniazid in combination with other drugs, such as rifapentine, is expected to fuel segment growth.
• Healthcare Spending: Rising healthcare spending, particularly in regions like the United States where healthcare spending is projected to reach USD 6.8 trillion by 2030, will also drive market growth[2].

Geographic Segmentation

The market is segmented geographically, with significant growth expected in regions such as Asia-Pacific, Africa, and South America, where TB prevalence is high.

• Country-Specific Data: The market report covers estimated market sizes and trends for 17 different countries across major regions globally, providing a detailed outlook on regional market dynamics[2].

Key Takeaways

• Clinical Efficacy: Rifampin and isoniazid are highly effective in treating LTBI and active TB, with rifampin showing better compliance and safety profiles in some studies.
• Market Growth: The anti-tuberculosis therapeutics market is expected to grow significantly, driven by rising TB prevalence, government initiatives, and increasing healthcare spending.
• Segment Growth: The isoniazid segment is anticipated to register high growth due to its widespread use and new treatment regimens.
• Challenges: Despite growth, the market faces challenges such as adverse side effects and the high cost of MDR and XDR TB drugs.

FAQs

What are the primary drugs used in treating latent tuberculosis infection (LTBI)?

The primary drugs used in treating LTBI are isoniazid and rifampin. Isoniazid is traditionally used for a 9-month regimen, while rifampin is often used for a shorter 4-month regimen.

How do rifampin and isoniazid compare in terms of treatment completion rates?

Rifampin has been shown to have higher treatment completion rates compared to isoniazid. A study found that 71.6% of patients completed the 4-month rifampin regimen, whereas only 52.6% completed the 9-month isoniazid regimen[1].

What are the common adverse reactions associated with isoniazid and rifampin?

Isoniazid is more commonly associated with hepatotoxicity and other adverse reactions, leading to higher rates of treatment discontinuation compared to rifampin. Rifampin has a lower incidence of clinically recognized adverse reactions[1].

How is the anti-tuberculosis therapeutics market expected to grow in the forecast period?

The anti-tuberculosis therapeutics market is expected to grow at a CAGR of 6.2% by 2027, driven by rising TB prevalence, government initiatives, and increasing healthcare spending[2].

What are the key drivers of the anti-tuberculosis therapeutics market?

The key drivers include the rising prevalence of tuberculosis, growing government initiatives for TB awareness, and the rising incidence of MDR and XDR TB cases[2].

What are the restraints to the growth of the anti-tuberculosis therapeutics market?

The restraints include adverse side effects of anti-tuberculosis drugs and the high cost of treating MDR and XDR TB[2].

Sources

1. Page KR, Sifakis F, Montes de Oca R, et al. Improved Adherence and Less Toxicity With Rifampin vs Isoniazid for Treatment of Latent Tuberculosis: A Retrospective Study. Arch Intern Med. 2006;166(17):1863–1870. doi:10.1001/archinte.166.17.1863
2. Mordor Intelligence. Anti-tuberculosis Therapeutics Market Size & Share Analysis.
3. Clinical Infectious Diseases. Intermediate Susceptibility Dose-Dependent Breakpoints For High Dose First-Line Antituberculosis Drugs.
4. Clinical Infectious Diseases. Effectiveness of a 9-Month Regimen of Isoniazid Alone versus 3- and 4-Month Regimens of Isoniazid plus Rifampin for Treatment of Latent Tuberculosis Infection in Children.
5. GlobeNewswire. Tuberculosis Drugs Market Research Report by Disease Type, by Drug Class, Global Forecast to 2025 - Cumulative Impact of COVID-19.