User Guide for “Efficacy and safety of discontinuing cotrimoxazole prophylaxis among HIV infected adults stabilized on ART in Uganda: randomised controlled trial”

Permanent Identifier:

https://doi.org/10.17037/DATA.00000917

Data Description

Cotrimoxazole (CTX) prophylaxis is recommended by the World Health Organisation for HIV infected persons. However, once HIV infected patients have commenced anti-retroviral treatment (ART), the benefits of continued CTX prophylaxis are not known. The COSTOP randomised controlled trial sought to assess the efficacy and safety of discontinuing cotrimoxazole prophylaxis among HIV infected adults stabilized on ART in Uganda. This data collection contains 12 individual-level datasets associated with the study. It covers: time to the first clinical event; time to first grade 3-4 laboratory adverse event; Adherence to CTX, ART and ITN; all-cause mortality; all grade 3-4 haematological adverse events; laboratory parameters and CD4 counts at week 48; number of episodes of haematological grade 3-4 AEs; time to first hospital admission; and a sensitivity analysis.

Geographic regions

Uganda

Key dates

Data Collection Period: 3 January 2011 - 30 June 2014

Species:

Human population

Ethics

MRC/UVRI and LSHTM Uganda research unit ethics approval ID: GC/127/10/07/02.

Keywords

Cotrimoxazole prophylaxis, HIV infections, HIV positive, Anti-retroviral treatment, Randomised controlled trial

Language of written material

English

Project title

Safety of discontinuing Cotrimoxazole prophylaxis among HIV infected adults on ART in Uganda. A randomised controlled trial (COSTOP)

Funder/Sponsor

• Medical Research Council
• Department for International Development
• European and Developing Countries Clinical Trials Partnership
• European Commission

Grant Number

G0902150

Additional Information

Data access requests will be evaluated by the following people: [1] Zacchaeus Anywaine; [2] Jonathan Levin; [3] Heiner Grosskurth; and [4] Ayoub Kakande. Additional support will be provided by the LSHTM Research Data Manager.

Data Creators

Associated Roles

File Description