CLINICAL TRIALS PROFILE FOR ISONIAZID; RIFAMPIN

All Clinical Trials for Isoniazid; Rifampin

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.
NCT00000638 ↗	Preventive Treatment 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 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.
NCT00000796 ↗	A Prospective Study of Multidrug Resistance and a Pilot Study of the Safety of and Clinical and Microbiologic Response to Levofloxacin in Combination With Other Antimycobacterial Drugs for Treatment of Multidrug-Resistant Pulmonary Tuberculosis (MDR	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To determine the demographic, behavioral, clinical, and geographic risk factors associated with the occurrence of multidrug-resistant pulmonary tuberculosis (MDRTB). To evaluate the clinical and microbiological responses and overall survival of MDRTB patients who are treated with levofloxacin-containing multiple-drug regimens chosen from a hierarchical list. Per 9/28/94 amendment, to assess whether persistent or recurrent positive sputum cultures of patients who show failure or relapse are due to the same strain or reinfection with a new strain. Among TB patients, there has been an increase in progressive disease due to the emergence of antimycobacterial drug-resistant strains of Mycobacterium tuberculosis. Failure to identify patients at high risk for MDRTB increases the hazard for both treatment failure and development of resistance to additional therapeutic agents. Efforts to improve survival in patients with MDRTB will depend on improved methods of assessing the risk of acquisition of MDRTB and identifying drug susceptibility patterns in a timely fashion.
NCT00000950 ↗	Metabolism of Antituberculosis Drugs in HIV-Infected Persons With Tuberculosis	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	The purpose of this study is to determine if a relationship exists between the level of antituberculosis drugs (isoniazid, rifampin, ethambutol, and pyrazinamide) in the blood and the outcome of HIV-positive patients with tuberculosis. This study also evaluates how these drugs are absorbed and metabolized in the body.
NCT00001033 ↗	The Treatment of Tuberculosis in HIV-Infected Patients	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1969-12-31	PER 5/30/95 AMENDMENT: To compare the combined rate of failure during therapy and relapse after therapy between two durations of intermittent therapy (6 versus 9 months) for the treatment of pulmonary tuberculosis (TB) in HIV-infected patients. To compare toxicity, survival, and development of resistance in these two regimens. ORIGINAL: To compare the efficacy and safety of induction and continuation therapies for the treatment of pulmonary TB in HIV-infected patients who are either from areas with known high rates of resistance to one or more anti-TB drugs or from areas where TB is expected to be susceptible to commonly used anti-TB drugs. PER 5/30/95 AMENDMENT: In HIV-negative patients, intermittent anti-TB therapy has been shown to be as effective as daily therapy, but the optimal duration of therapy in HIV-infected patients has not been established. ORIGINAL: In some areas of the country, resistance to one or more of the drugs commonly used to treat TB has emerged. Thus, the need to test regimens containing a new drug exists. Furthermore, the optimal duration of anti-TB therapy for HIV-infected patients with TB needs to be determined.

Clinical Trial Conditions for Isoniazid; Rifampin

Condition Name

Condition Name for Isoniazid; Rifampin
Intervention	Trials
Tuberculosis	28
HIV Infections	8
Tuberculosis, Pulmonary	7
Pulmonary Tuberculosis	6

Condition MeSH

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

Clinical Trial Locations for Isoniazid; Rifampin

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for Isoniazid; Rifampin

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for Isoniazid; Rifampin

Sponsor Name

Sponsor Name for Isoniazid; Rifampin
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 Isoniazid; Rifampin
Sponsor	Trials
Other	126
U.S. Fed	16
Industry	12

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

Introduction to Isoniazid and Rifampin

Isoniazid and rifampin are two of the most critical drugs in the treatment of tuberculosis (TB), a global health issue affecting millions. Here, we will delve into the latest clinical trials, market analysis, and projections for these essential anti-TB medications.

Clinical Trials Update

Isoniazid and Rifampin in Latent TB Infection (LTBI)

Clinical trials have consistently shown that rifampin regimens offer several advantages over traditional isoniazid regimens for treating LTBI. A retrospective study published in the Archives of Internal Medicine found that a 4-month rifampin regimen had higher treatment completion rates (71.6% vs 52.6%) and lower toxicity compared to a 9-month isoniazid regimen[1][5].

Rifamycin-Based Regimens

The CDC recommends rifamycin-based regimens, including 3 months of once-weekly isoniazid plus rifapentine, 4 months of daily rifampin, and 3 months of daily isoniazid plus rifampin, due to their effectiveness, safety, and high treatment completion rates[4].

New Drug Regimens

The TB Alliance has been conducting several clinical trials to evaluate new and potentially shorter drug regimens. For example, the SimpliciTB trial is testing the BPaMZ regimen (bedaquiline, pretomanid, moxifloxacin, and pyrazinamide) for patients with drug-sensitive (DS) and multidrug-resistant (MDR) TB. This regimen is administered for four months for DS-TB and six months for MDR-TB or mono-resistance to rifampicin or isoniazid[3].

Other Notable Trials

• The REMoxTB trial tested whether substituting moxifloxacin for a single drug in the standard TB therapy could reduce treatment duration for drug-sensitive disease from six months to four[3].
• The Nix-TB trial, which tested the BPaL regimen (bedaquiline, pretomanid, and linezolid), showed a favorable outcome in 90% of patients with XDR-TB or treatment-intolerant MDR-TB at six months after treatment[3].

Market Analysis

Market Size and Growth

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

Isoniazid Segment

Isoniazid is anticipated to register a high CAGR in the anti-tuberculosis therapeutics market. This growth is attributed to the rising prevalence of TB and the adoption of isoniazid in combination with other drugs for treating TB. For instance, high-dose isoniazid has shown early bactericidal activity for Mycobacterium tuberculosis strains with inhA mutations, making it a valuable addition to second-line TB therapy regimens[2].

Rifampin Segment

Rifampin, another key player in TB treatment, is also expected to see significant growth. The preference for rifamycin-based regimens due to their higher treatment completion rates and lower toxicity will continue to drive the demand for rifampin[1][4].

Market Drivers

Rising Prevalence of Tuberculosis

The increasing incidence of TB, particularly in developing countries, is a major driver for the anti-tuberculosis drugs market. This rise is compounded by the emergence of multidrug-resistant (MDR) and extensively drug-resistant (XDR) TB cases[2].

Government Initiatives

Government organizations and global health bodies are increasing their efforts to raise awareness and improve treatment access for TB. These initiatives include the development and implementation of new treatment regimens and the promotion of existing effective treatments like rifampin and isoniazid[2].

Market Restraints

Adverse Side Effects

One of the significant restraints for the anti-tuberculosis drugs market is the adverse side effects associated with these medications. Isoniazid, in particular, is known for its hepatotoxicity, which can lead to treatment discontinuation[1][2].

High Cost of MDR and XDR TB Drugs

The high cost of drugs for treating MDR and XDR TB is another restraint. Newer regimens, while effective, can be expensive, making them less accessible in resource-poor settings[2].

Projections and Future Outlook

Increasing Adoption of Shorter Regimens

The trend towards shorter treatment regimens, such as the 4-month rifampin regimen, is expected to continue. These regimens offer better compliance and lower toxicity, which will drive their adoption in both developed and developing countries[1][4].

Innovations in Drug Formulations

The development of child-friendly formulations and fixed-dose combinations, such as the rifapentine and isoniazid combination, will simplify treatment regimens and reduce the pill burden, further boosting market growth[2][3].

Emerging Markets

Countries with high TB burdens, such as Ethiopia, Ghana, Kenya, Mozambique, and Zimbabwe, are piloting new short-course treatment regimens. These initiatives will expand the market for anti-tuberculosis drugs, including isoniazid and rifampin[2].

Key Takeaways

• Clinical Trials: Rifampin regimens show higher treatment completion rates and lower toxicity compared to traditional isoniazid regimens for LTBI.
• Market Growth: The anti-tuberculosis therapeutics market is expected to grow at a CAGR of 6.2% by 2027, driven by rising TB prevalence and government initiatives.
• Isoniazid Segment: Expected to register high CAGR due to its adoption in combination therapies and high-dose regimens for MDR-TB.
• Rifampin Segment: Preferred due to higher treatment completion rates and lower toxicity.
• Market Drivers: Rising TB prevalence, government initiatives, and innovations in drug formulations.
• Market Restraints: Adverse side effects and high costs of MDR and XDR TB drugs.

FAQs

Q1: What are the main differences between isoniazid and rifampin in treating latent TB infection?

A1: Rifampin regimens have higher treatment completion rates and lower toxicity compared to traditional 9-month isoniazid regimens. Rifampin is typically administered for 4 months, while isoniazid is given for 9 months[1][5].

Q2: How is the market for anti-tuberculosis drugs expected to grow?

A2: The market is expected to grow at a CAGR of 6.2% by 2027, driven by rising TB prevalence and government initiatives for TB awareness[2].

Q3: What are some of the new drug regimens being tested for TB treatment?

A3: New regimens include the BPaMZ regimen (bedaquiline, pretomanid, moxifloxacin, and pyrazinamide) and the BPaL regimen (bedaquiline, pretomanid, and linezolid) for drug-sensitive and multidrug-resistant TB[3].

Q4: What are the main restraints for the anti-tuberculosis drugs market?

A4: The main restraints are adverse side effects associated with these medications, particularly hepatotoxicity from isoniazid, and the high cost of drugs for treating MDR and XDR TB[1][2].

Q5: How are government initiatives impacting the market for anti-tuberculosis drugs?

A5: Government initiatives are increasing awareness and improving treatment access. They are also promoting the development and implementation of new, more effective treatment regimens, which is driving market growth[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. TB Alliance. Trials - TB Alliance.
4. CDC. Guidelines for the Treatment of Latent Tuberculosis Infection.
5. Academic.oup.com. 4 Months of Rifampin Compared with 9 Months of Isoniazid for the Treatment of Latent Tuberculosis Infection.

Last updated: 2025-01-05