Clinical trial NCT00398996: A Study to Compare Three Existing Starting Points of Anti-Retroviral Therapy (ART) Initiation in HIV/Tuberculosis (TB) Co-infected Patients
Official title: Study to Compare Three Existing Starting Points of ART Initiation in HIV/TB Co-infected Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Tuberculosis
Keywords: antiretroviral therapy
HIV
Opportunistic infections
CD4
Viral load
TB/HIV co infection
Treatment Naive
Lead sponsor: Centre for the AIDS Programme of Research in South Africa
Sponsor class: NETWORK
First posted: 2006-11-14
Enrollment: 642
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: To measure the incidence of progression to AIDS defining illness or mortality
timeFrame: 18 months
Secondary outcomes:
measure: A comparison of CD4+ cell count, viral load, opportunistic infections across the 3 study arms
timeFrame: 18 months
Other outcomes:
Locations:
city: Durban
country: South Africa
facility: CAPRISA eThekwini Clinical Research Site
state: KwaZulu-Natal
Study officials:
affiliation: CAPRISA, University of KwaZulu-Natal
name: Salim S Abdool karim, MBChB, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1097/00002030-200404300-00004. No abstract available.
citation: 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.
citation: 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.
citation: 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.