Phase 4
N=806
Immediate Versus Deferred Start of Anti-HIV Therapy in HIV-Infected Adults Being Treated for Tuberculosis
HIV Infection · Tuberculosis
Bottom Line
View on ClinicalTrials.gov: NCT00108862 ↗Enrolled (actual)
806
Serious AEs
12.3%
Results posted
Nov 2011
Primary outcome: Primary: Percent of Participants Who Survived Without AIDS Progression. — 13; 16 percent of participants — p=0.45
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Strategy: Immediate ART (Other); Strategy: Deferred ART (Other)
- Age
- Pediatric, Adult, Older Adult · 13+ yrs
- Sex
- All
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Participants Who Survived Without AIDS Progression. |
13; 16 | 0.45 |
| SECONDARY Percent of Participants Reporting a Grade 3 or 4 Adverse Event or Laboratory Abnormality |
44; 47 | — |
| SECONDARY Time to First New AIDS-defining Illness or Death. |
4; 7; 13; 12 | — |
| SECONDARY Percent of Participants With Culture-confirmed Tuberculosis (TB) Who Survived Without AIDS Progression. |
12; 17 | — |
| SECONDARY Percent of Participants Who Interrupted or Discontinued at Least One Tuberculosis (TB) Medication Due to Toxicity. |
9; 10 | — |
| SECONDARY Percent of Participants With Confirmed or Probable Tuberculosis (TB) Whose TB Resolved, or Who Required TB Treatment Through the End of Follow-up, or Died, or Were Lost to Follow-up. |
79; 82; 6; 5; 6; 7 | — |
| SECONDARY Percent of Participants Whose CD4 Increased by at Least 100 Cells/mm^3 Between Baseline and Week 48. |
60; 60; 32; 31; 8; 9 | — |
| SECONDARY Percent of Participants With MTB IRIS. |
11; 5 | — |
| SECONDARY Percent of Participants With HIV IRIS. |
3; 3 | — |
| SECONDARY Percent of Participants Whose HIV Viral Load Was Less Than 400 Copies/mL at Week 48. |
72; 75; 20; 16; 8; 9 | — |
Summary
The purpose of this study is to determine the best time to begin anti-HIV treatment in individuals who have HIV and tuberculosis (TB).
Study hypothesis: Immediate antiretroviral therapy (ART), initiated after approximately 2 weeks of TB treatment, will reduce the frequency of other AIDS-defining illnesses and death in HIV-infected participants being treated for TB by at least 40% at week 48 when compared to deferred ART, initiated at after 8-12 weeks of TB treatment.
Eligibility Criteria
Inclusion Criteria
- HIV-infected.
- Confirmed or probable TB (more information on the criterion can be found in the protocol).
- Chest x-ray within 30 days prior to study entry.
- Receipt of 1-14 cumulative days of rifampin- or other rifamycin-based TB treatment that was initiated within 28 days prior to study entry.
- CD4 count less than 250 cells/mm^3 within 30 days prior to study entry.
- Willing to use acceptable methods of contraception while on study drugs and for 6 weeks after stopping these drugs.
- Able to swallow oral medications.
- Parent of guardian willing to provide informed consent, if applicable.
- Karnofsky performance score =>20 at time of study entry.
Exclusion Criteria
- ART for longer than 7 cumulative days prior to study entry or treatment for any period of time with one or more antiretrovirals. Participants who have taken ART during pregnancy or for occupational exposure are not excluded.
- Allergy or sensitivity to any of the study drugs or their formulations.
- History of multidrug-resistant TB.
- Receipt of any investigational therapy or chemotherapy within 30 days prior to study entry.
- Certain medications.
- Breastfeeding.
Data sourced from ClinicalTrials.gov (NCT00108862). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.