NCT00523458

Brief Summary

Because drugs used to treat TB can reduce the amount of the anti-HIV drugs that reach the sites where the virus is located, this study is designed to see whether it is necessary to use higher doses of antiviral (anti-HIV) drugs while patients are receiving therapy with rifampin, one of the drugs commonly used to treat TB. Participants will be assigned to one of 4 arms (see below) and will be followed during the time when they are receiving both treatments.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_4 hiv-infections

Timeline
Completed

Started Jul 2007

Shorter than P25 for phase_4 hiv-infections

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

July 22, 2011

Status Verified

July 1, 2011

Enrollment Period

8 months

First QC Date

August 29, 2007

Last Update Submit

July 20, 2011

Conditions

HIV InfectionsTuberculosis

Keywords

Co-infectionTuberculosisHIVDrug interactionsNon nucleoside reverse transcriptase inhibitorsTherapyTreatment Naive

Outcome Measures

Primary Outcomes (1)

  • Decline in HIV RNA in plasma Rise in CD4 cell count

    These laboratory measures would be used to determine if there was a difference in the ARV failure rate between patients receiving standard dose vs high dose treatment with NNRTIs

    Baseline, and Weeks 8, 20 and 32

Study Arms (4)

1

ACTIVE COMPARATOR

Standard dose nevirapine (200 mg 2x daily) in combination with 2 nucleoside analogs

Drug: efavirenz or nevirapine

2

EXPERIMENTAL

High dose nevirapine (400 mg in the morning, 200 mg in the evening) in combination with 2 nucleoside analogs

Drug: efavirenz or nevirapine

3

ACTIVE COMPARATOR

Standard dose efavirenz (600 mg at bedtime) in combination with 2 nucleoside analogs

Drug: efavirenz or nevirapine

4

EXPERIMENTAL

High dose efavirenz (800 mg at bedtime) in combination with 2 nucleoside analogs

Drug: efavirenz or nevirapine

Interventions

efavirenz or nevirapineDRUG

Patients co-infected with HIV and TB will receive either "standard" doses of nevirapine (200 mg 2x daily) or efavirenz (600 mg daily) or "high" doses of nevirapine (400 mg and 200 mg daily) or efavirenz (800 mg daily) that are chosen to compensate for the change in pharmacokinetics shown to occur when co-infected patients are treated with the antituberculous drug, rifampin.

Also known as: Sustiva (efavirenz), Viramune (nevirapine)
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Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ARV naïve subjects
  • Documented HIV infection
  • Documented TB infection
  • Platelet count 40,000/mm3
  • Hemoglobin ≥8.0 g/dL
  • Absolute neutrophil count (ANC) \>500/mm3
  • AST (SGOT), ALT (SGPT), and alkaline phosphatase \<3 X ULN
  • Total bilirubin \<2.5 x ULN
  • Calculated creatinine clearance ≥60 mL/min
  • For women of reproductive potential, negative urine pregnancy test

You may not qualify if:

  • Unable to provide informed consent.
  • History drug abuse that the investigators suspect will interfere with compliance to study medications and visits.
  • Patients on hemodialysis.
  • Tuberculosis meningitis.
  • Women with CD4 \> 250 and men with CD4 \> 400 due to higher risk of hepatotoxicity related to use of NVP.
  • Positive serology for hepatitis C.
  • Women who are breast-feeding
  • Known allergy/sensitivity to study drug(s) or their formulations
  • Patients with other OIs or intercurrent illness that could affect their ability to take study drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Prof. Edgard Santos/Universidade Federal da Bahia

Salvador, Estado de Bahia, 40110-160, Brazil

Location

MeSH Terms

Conditions

HIV InfectionsTuberculosisCoinfection

Interventions

efavirenzNevirapine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Terrence F Blaschke, M.D.

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 29, 2007

First Posted

August 31, 2007

Study Start

July 1, 2007

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

July 22, 2011

Record last verified: 2011-07

Locations

BR(1)