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Clinical Trials/CTRI/2012/11/003088
CTRI/2012/11/003088
Other
Phase 4

REMEMBER: Reducing Early Mortality and Morbidity by Empiric Tuberculosis (TB) Treatment

AIDS Clinical Trials Group National Institute of Allergy and Infectious Diseases NIAID USA0 sites836 target enrollmentTBD
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ConditionsHealth Condition 1: null- HIV Infection

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Health Condition 1: null- HIV Infection
Sponsor
AIDS Clinical Trials Group National Institute of Allergy and Infectious Diseases NIAID USA
Enrollment
836
Status
Other
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
AIDS Clinical Trials Group National Institute of Allergy and Infectious Diseases NIAID USA

Eligibility Criteria

Inclusion Criteria

  • •HIV\-1 infection
  • •Willingness to start efavirenz\-based ART as soon as possible and within no more than 3 days following randomization.
  • •CD4\+ cell count \<50 cells/mm3 obtained within 45 days prior to study entry at any laboratory that has a CLIA certification or its equivalent.
  • •Aspartate aminotransferase AST\- SGOT alanine aminotransferase ALT\- SGPT and total bilirubin \<\= 2\.5 X ULN within 30 days prior to study entry.
  • •Creatinine clearance \>\=30 mL/min either measured or estimated using values obtained within 30 days prior to study entry.
  • •Agreement not to participate in a conception process e.g., active attempt to become pregnant or to impregnate, donate sperm, in vitro fertilization
  • •Female candidates of reproductive potential must have a negative serum or urine 15\-25 mI pregnancy test result within 7 days prior to study entry.
  • •Female candidates of reproductive potential who are participating in sexual activity that could lead to pregnancy must use two reliable methods of contraception while on study.
  • •Males and females age 18 years.
  • •Ability to swallow medications.

Exclusion Criteria

  • •Presence of any confirmed or probable TB based on criteria listed in the current ACTG diagnosis appendix within 30 days prior to study entry and following completion of study\-specific screening algorithm.
  • •Use of single\-dose NVP for prevention of mother\-to\-child transmission pMTCT within 24 months prior to study entry.
  • •Use of prohibited medications within 30 days prior to study entry.
  • •Known allergy\-ensitivity or any hypersensitivity to components of study\-required ART or TB treatment.
  • •Current receipt of treatment for active TB or receipt of 14 days cumulative treatment for active TB within 96 weeks prior to study entry.
  • •Receipt of 30 days cumulative of INH prophylaxis within 48 weeks prior to study entry.
  • •Receipt at any time prior to study entry of 7 days cumulative treatment with any ARV or combination of ARVs (except for ARVs taken for any length of time during pregnancy for pMTCT, or ARVs taken for occupational exposure.
  • •Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
  • •Current Grade 2 neuropathy.
  • •History of multi\-drug\-resistant (MDR) TB.

Outcomes

Primary Outcomes

Not specified

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