|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsored by: |
Centre for the AIDS Programme of Research in South Africa |
|---|---|
| Information provided by: | Centre for the AIDS Programme of Research in South Africa |
| ClinicalTrials.gov Identifier: | NCT00398996 |
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 follow up 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 III |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
Whole blood for ARV resistance testing
| Estimated Enrollment: | 700 |
| Study Start Date: | June 2005 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
Smear positive pulmonary TB and HIV co-infected patients who are >18 years and ambulant
|
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 |
| Sampling Method: | Non-Probability Sample |
Adult patients that are ambulant and are TB smear positive and co infected with HIV
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Kogie Naidoo, MBChB | +27 31 260 4687 | naidook45@ukzn.ac.za |
| Contact: Jacqueline Pienaar | +27 31 260 1905 | pienaar@ukzn.ac.za |
| South Africa, KwaZulu-Natal | |
| CAPRISA eThekwini Clinical Research Site | Recruiting |
| Durban, KwaZulu-Natal, South Africa, 4001 | |
| Contact: Kogie Naidoo, MBChB +27 31 260 4687 naidook45@ukzn.ac.za | |
| Sub-Investigator: Kogie Naidoo, MBChB | |
| Principal Investigator: Salim S Abdool Karim, MBChB, PhD | |
| Principal Investigator: | Salim S Abdool karim, MBChB, PhD | CAPRISA, University of KwaZulu-Natal |
More Information
| Responsible Party: | CAPRISA ( Director: Prof Salim S Abdool Karim ) |
| Study ID Numbers: | CAPRISA 003 |
| Study First Received: | November 7, 2006 |
| Last Updated: | February 25, 2008 |
| ClinicalTrials.gov Identifier: | NCT00398996 |
| Health Authority: | South Africa: Medicines Control Council |
|
antiretroviral therapy HIV Opportunistic infections CD4 |
Viral load TB/HIV co infection Treatment Naive |
|
Bacterial Infections Opportunistic Infections Sexually Transmitted Diseases, Viral Acquired Immunodeficiency Syndrome Lamivudine Immunologic Deficiency Syndromes Virus Diseases |
Gram-Positive Bacterial Infections HIV Infections Sexually Transmitted Diseases Mycobacterium Infections Tuberculosis Retroviridae Infections |
|
RNA Virus Infections Slow Virus Diseases Immune System Diseases |
Lentivirus Infections Infection Actinomycetales Infections |
