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

Purpose

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.

Condition	Intervention	Phase
HIV Infections Tuberculosis	Drug: Early versus intermediate versus late initiation of ART	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Study to Compare Three Existing Starting Points of ART Initiation in HIV/TB Co-infected Patients

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Tuberculosis

Genetic and Rare Diseases Information Center resources: Tuberculosis

U.S. FDA Resources

Further study details as provided by Centre for the AIDS Programme of Research in South Africa:

Primary Outcome Measures:

To measure the incidence of progression to AIDS defining illness or mortality [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

A comparison of CD4+ cell count, viral load, opportunistic infections across the 3 study arms [ Time Frame: 18 months ] [ Designated as safety issue: No ]


Enrollment:	642
Study Start Date:	June 2005
Study Completion Date:	July 2010
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 - Early integrated-therapy group antiretroviral therapy to be initiated within 4 weeks of starting tuberculosis treatment	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
Active Comparator: 2 - Late integrated-therapy group antiretroviral therapy to be initiated within 4 weeks of completing the intensive phase of tuberculosis treatment	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
Active Comparator: 3 - Sequential-therapy group Antiretroviral therapy to be initiated within 4 weeks after completing tuberculosis treatment	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

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00398996

Locations


South Africa
CAPRISA eThekwini Clinical Research Site
Durban, KwaZulu-Natal, South Africa, 4001

Sponsors and Collaborators

Centre for the AIDS Programme of Research in South Africa

Investigators


Principal Investigator:	Salim S Abdool karim, MBChB, PhD	CAPRISA, University of KwaZulu-Natal

More Information

Publications:

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. 2010 Feb 25;362(8):697-706. doi: 10.1056/NEJMoa0905848.

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Naidoo K, Yende-Zuma N, Padayatchi N, Naidoo K, Jithoo N, Nair G, Bamber S, Gengiah S, El-Sadr WM, Friedland G, Abdool Karim S. The immune reconstitution inflammatory syndrome after antiretroviral therapy initiation in patients with tuberculosis: findings from the SAPiT trial. Ann Intern Med. 2012 Sep 4;157(5):313-24. doi: 10.7326/0003-4819-157-5-201209040-00004.

Abdool Karim SS, Naidoo K, Grobler A, Padayatchi N, Baxter C, Gray AL, Gengiah T, Gengiah S, Naidoo A, Jithoo N, Nair G, El-Sadr WM, Friedland G, Abdool Karim Q. Integration of antiretroviral therapy with tuberculosis treatment. N Engl J Med. 2011 Oct 20;365(16):1492-501. doi: 10.1056/NEJMoa1014181.


Responsible Party:	Director: Prof Salim S Abdool Karim, CAPRISA
ClinicalTrials.gov Identifier:	NCT00398996 History of Changes
Other Study ID Numbers:	CAPRISA 003
Study First Received:	November 7, 2006
Last Updated:	March 23, 2011
Health Authority:	South Africa: Medicines Control Council

Keywords provided by Centre for the AIDS Programme of Research in South Africa:


antiretroviral therapy HIV Opportunistic infections CD4	Viral load TB/HIV co infection Treatment Naive

Additional relevant MeSH terms:


Tuberculosis Actinomycetales Infections Bacterial Infections Gram-Positive Bacterial Infections Mycobacterium Infections

ClinicalTrials.gov processed this record on February 27, 2015

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