NCT00476853

Brief Summary

A 48 week, randomized, open-label, two arm study to compare the efficacy, safety and tolerability of HAART containing nevirapine 400 mg/day versus nevirapine 600 mg/day in HIV-1 infected patients started at 2-6 weeks after initiating rifampicin containing antituberculosis therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for phase_2 hiv-infections

Timeline
Completed

Started Oct 2005

Typical duration for phase_2 hiv-infections

Geographic Reach
1 country

6 active sites

Status
completed

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

October 1, 2005

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

July 17, 2020

Status Verified

July 1, 2020

Enrollment Period

2.9 years

First QC Date

May 20, 2007

Last Update Submit

July 15, 2020

Conditions

HIV InfectionsTuberculosis

Keywords

HIV-TBnevirapine based HAART with rifampin treated TBCompare PK profile, efficacy, safety and tolerability of HAART containing nevirapine 400mg/day versus 600 mg/day in HIV/TB co-infected patientsTreatment Naive

Outcome Measures

Primary Outcomes (1)

  • Efficacy of nevirapine based HAART 400 mg/day versus 600 mg/day on HIV-1 load as measured by HIV-1 RNA quantification in plasma

    48 weeks

Secondary Outcomes (4)

  • Safety and tolerability of nevirapine based HAART 400 mg/day versus 600 mg/day

    48 weeks

  • Nevirapine level at week 2, 4 and 12 and 12 hour PK at week 4 (only 20 patients)

    48 weeks

  • Immune recovery syndrome, adherence, clinical improvement, incidence of new/recurrent AIDS events (CDC class C) between two group

    48 weeks

  • Time to mortality or new/recurrent AIDS events (CDC class C), 1 year mortality rate of TB/HIV patients, emerging of ARV resistant especially nevirapine, emerging of anti-TB resistance

    48 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

NVP 400 mg

Drug: HAART containing nevirapine

2

ACTIVE COMPARATOR

NVP 600 mg

Drug: HAART containing nevirapine

Interventions

HAART containing nevirapineDRUG

Initially NVP 200 mg BID (400 mg per day) was compared to 400 mg BID and 200 mg OD NVP (600 mg per day). 400 mg/day versus 600 mg/day.

12

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Confirmed HIV positive after voluntary counseling and testing
  • Aged 18-60 years of age
  • Antiretroviral treatment naïve.
  • CD4+ cell count of \< 200 cells/mm3 at the time of diagnosed TB
  • TB is diagnosed and using treatment with rifampin base therapy for at least 2 weeks but no longer than 4 weeks duration. The requirement for study entry is at least one acid-fast bacillus (AFB) positive smear with a typical syndrome and/or CXR findings consistent with pulmonary TB. Pulmonary TB and / or extra pulmonary TB will be included if AFB or culture for TB is positive.
  • No other active OI (CDC class C event)
  • Negative pregnancy test in females, and willing to use reliable contraception
  • Able to provide written informed consent.

You may not qualify if:

  • The following laboratory variables, i. absolute neutrophil count (ANC) \< 1000 cells/uL ii. hemoglobin \< 6.5 g/dL iii. platelet count \< 50,000 cells/uL iv. serum AST, ALT \> 5 x ULN vi. serum bilirubin \> 2 x ULN vii. serum creatinine \> 2 x ULN viii. Pregnant or nursing mothers.
  • Current use of steroid and other immunosuppressive agents.
  • Current use of any prohibited medications related to compliance and drug pharmacokinetics (see appendix )
  • Acute therapy for serious infection or other serious medical illness (in the judgment of the site Principal Investigator) requiring systemic treatment and/or hospitalization.
  • Patients with current alcohol or illicit substance use that in the opinion of the site Principal Investigator would conflict with any aspect of the conduct of the trial.
  • The persons who had been received a mono-therapy of nevirapine
  • Unlikely to be able to remain in follow-up for the protocol defined period.
  • Patients with chronic active liver disease.
  • Patients with proven or suspected acute hepatitis. Patients with chronic viral hepatitis are eligible provided ALT, AST \< 5 x ULN.
  • Karnofsky performance score \<30%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)

Bangkok, 10330, Thailand

Location

Chiangrai Hospital

Chiang Rai, 57000, Thailand

Location

Mae Chan Hospital

Chiang Rai, 57000, Thailand

Location

Phan Hospital

Chiang Rai, 57000, Thailand

Location

Bamrasnaradura Institute

Nonthaburi, 11000, Thailand

Location

Central Chest Hospital

Nonthaburi, 11000, Thailand

Location

Related Publications (1)

  • Avihingsanon A, Manosuthi W, Kantipong P, Chuchotaworn C, Moolphate S, Sakornjun W, Gorowara M, Yamada N, Yanai H, Mitarai S, Ishikawa N, Cooper DA, Phanuphak P, Burger D, Ruxrungtham K. Pharmacokinetics and 48-week efficacy of nevirapine: 400 mg versus 600 mg per day in HIV-tuberculosis coinfection receiving rifampicin. Antivir Ther. 2008;13(4):529-36.

    PMID: 18672531DERIVED

Related Links

MeSH Terms

Conditions

HIV InfectionsTuberculosis

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

Study Officials

  • Anchalee Avihingsanon, MD

    The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2007

First Posted

May 22, 2007

Study Start

October 1, 2005

Primary Completion

September 1, 2008

Study Completion

December 1, 2009

Last Updated

July 17, 2020

Record last verified: 2020-07

Locations

TH(6)