A Study to Compare Three Existing Starting Points of Anti-Retroviral Therapy (ART) Initiation in HIV/Tuberculosis (TB) Co-infected Patients

HIV Infections Clinical Trial

— SAPIT  

Official title:

Study to Compare Three Existing Starting Points of ART Initiation in HIV/TB Co-infected Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00398996
• Other study ID #: CAPRISA 003
• Status: Completed
• Phase: Phase 3
• First received: November 7, 2006
• Last updated: March 23, 2011
• Start date: June 2005
• Est. completion date: July 2010

Study information

• Verified date: March 2011
• Source: Centre for the AIDS Programme of Research in South Africa
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial Summary

This is a randomized, open-label study comparing three existing treatment strategies of ART initiation in HIV/TB co-infected patients:

Group 1: early initiation of ART with TB treatment, Group 2: initiation of ART upon completion of the intensive phase of TB treatment, Group 3: initiation of ART upon completion of the continuation phase of TB treatment

Approximately 700 men and women ≥ 18 years of age with documented HIV infection and smear-positive pulmonary TB patients will be enrolled. Eligible TB/HIV co-infected patients will be offered antiretroviral therapy (ART), starting at one of the three time points listed above through the CAPRISA AIDS treatment programme which includes extensive counselling and adherence support. The study participants will be followed for 18 months to assess the primary study endpoint of the optimal time to start antiretroviral therapy (ART) in patients on tuberculosis (TB) treatment by comparing clinical status (CD4+ cell count, viral load, opportunistic infections.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 642
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• HIV infected patients co-infected with TB

• Receiving any one of the standard anti-TB therapy regimens

• All patients must agree to use contraception since they will be on efavirenz.

Exclusion Criteria:

• Entry into the treatment programme is based on a clinical assessment and should patients not be clinically eligible to maintain a treatment regimen,their entry may be deferred or precluded

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Tuberculosis

Intervention

Drug:
• Early versus intermediate versus late initiation of ART
Initiation of once daily ddI (400 / 250mg), 3TC (300mg) and EFV (600mg)during the intensive phase of TB therapy or during the continuation phase of TB therapy or once TB therapy has been completed

Locations

Country	Name	City	State
South Africa	CAPRISA eThekwini Clinical Research Site	Durban	KwaZulu-Natal

Sponsors (1)

Lead Sponsor	Collaborator
Centre for the AIDS Programme of Research in South Africa

Country where clinical trial is conducted

South Africa, 

References & Publications (2)

Abdool Karim SS, Naidoo K, Grobler A, Padayatchi N, Baxter C, Gray A, Gengiah T, Nair G, Bamber S, Singh A, Khan M, Pienaar J, El-Sadr W, Friedland G, Abdool Karim Q. Timing of initiation of antiretroviral drugs during tuberculosis therapy. N Engl J Med. — View Citation

Abdool-Karim SS, Abdool-Karim Q, Friedland G, Lalloo U, El-Sadr WM; START project. Implementing antiretroviral therapy in resource-constrained settings: opportunities and challenges in integrating HIV and tuberculosis care. AIDS. 2004 Apr 30;18(7):975-9. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To measure the incidence of progression to AIDS defining illness or mortality		18 months	Yes
Secondary	A comparison of CD4+ cell count, viral load, opportunistic infections across the 3 study arms		18 months	No

External Links

•   Centre for the AIDS Programme of Research in South Africa's website