Efficacy and Safety of Concomitant Use of Nevirapine and Rifampicin With HIV-TB

Summary

The purpose of the study is to evaluate the efficacy and safety of Nevarapine and Rifampicin vs Efavirenz and Rifampicin in antiretroviral naive patients co-infected with HIV and TB and to investigate whether Rifampicin co-administration in clinical practice leads to a clinically relevant decrease of Nevirapine plasma concentrations in Indian patients co-infected with HIV and Tuberculosis and to characterize drug-associated toxicities (especially hepatic).

Timeline

Start

2007-06

Primary completion

2012-12

Completion

2013-02

Outcome

Missed primary endpoint

paper Composite unfavourable outcome in HIV-TB co-infected patients who were ART-naïve showed no statistically significant difference in the Nevirapine or Efavirenz groups. PMID 29228918 ↗

Publications

• Sinha S, Gupta K, Tripathy S, Dhooria S, Ranjan S, Pandey RM. Nevirapine- versus Efavirenz-based antiretroviral therapy regimens in antiretroviral-naive patients with HIV and Tuberculosis infections in India: a multi-centre study. BMC Infect Dis. 2017 Dec 11;17(1):761. doi: 10.1186/s12879-017-2864-0.
• Sinha S, Raghunandan P, Chandrashekhar R, Sharma SK, Kumar S, Dhooria S, Ekka M, Velpandian T, Ranjan S, Ahmad H, Samantaray JC, Venkatesh S, Rewari BB, Khan NH, Pandey RM. Nevirapine versus efavirenz-based antiretroviral therapy regimens in antiretroviral-naive patients with HIV and tuberculosis infections in India: a pilot study. BMC Infect Dis. 2013 Oct 17;13:482. doi: 10.1186/1471-2334-13-482.

Drugs

Indications