---
title: Efficacy of Tenofovir-Emtricitabine and Efavirenz in HIV Infected Patients With Tuberculosis (ANRS129)
nct_id: NCT00115609
overall_status: COMPLETED
phase: PHASE3
sponsor: French National Agency for Research on AIDS and Viral Hepatitis
study_type: INTERVENTIONAL
primary_condition: HIV Infections
countries: France
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00115609.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00115609"
ct_last_update_post_date: 2026-04-08
last_seen_at: "2026-05-12T07:23:37.184Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Efficacy of Tenofovir-Emtricitabine and Efavirenz in HIV Infected Patients With Tuberculosis (ANRS129)

**Official Title:** Pilot Trial Evaluating Once Daily Triple Combination Antiretroviral Therapy With Tenofovir-Emtricitabine and Efavirenz in HIV-1 Infected Patients With Mycobacterium Tuberculosis Infection ANRS129 BKVIR

**NCT ID:** [NCT00115609](https://clinicaltrials.gov/study/NCT00115609)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 70
- **Lead Sponsor:** French National Agency for Research on AIDS and Viral Hepatitis
- **Conditions:** HIV Infections, Tuberculosis
- **Start Date:** 2006-01
- **Completion Date:** 2009-11
- **CT.gov Last Update:** 2026-04-08

## Brief Summary

Successful therapy of both tuberculosis and HIV disease share similar problems: pill burden, drug interaction, adherence challenge and toxicity. This study will test the efficacy and safety of a once daily antiretroviral regimen in HIV-tuberculosis coinfected patients.

## Detailed Description

The proposed research consists of conducting a pilot trial "BKVIR" designed to answer the question of whether once daily tenofovir-emtricitabine-efavirenz triple-agent therapy is effective and well tolerated when it must be initiated within three months after initiation of a three-agent or four-agent tuberculostatic therapy in antiretroviral-naive HIV-infected patients. As the proposed pilot trial comprises the initiation of antiretroviral therapy during the three months following the initiation of tuberculostatic therapy, we propose to set up systematic, continuous registration of HIV-infected patients with a diagnosis of tuberculosis in participating centers during the study period in order to evaluate their eligibility for inclusion in the pilot trial. The initial declaration phase in the register, in addition to facilitating inclusions in the pilot trial, should also allow: 1) a better understanding of the reasons for non-inclusion in the trial, allowing the eligibility criteria to be adjusted if necessary during the trial; and 2) to describe the antiretroviral therapies used during co-infection and their time of initiation in relation to tuberculostatic therapy.

This research is expected to contribute to an updating of the treatment guidelines in the context of tuberculosis in HIV-infected patients. The data collected will constitute a unique database on this issue not only in France, but also internationally, which will also be useful to optimize management strategies of these two diseases in developing countries.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Patients ≥ 18 years
* Infected by HIV-1
* Naive to antiretroviral therapy
* Presenting an indication to start antiretroviral therapy (according to the recommendations of the Delfraissy 2004 report)
* Histologically or microbiologically confirmed tuberculosis
* Receiving tuberculostatic therapy for less than three months

Exclusion Criteria:

* Isolated HIV-2 infection
* Neoplasm treated by chemotherapy and/or radiotherapy
* Pregnancy or plans for pregnancy
* Breastfeeding
* Contraindication to one of the antiretroviral drugs
* Atypical mycobacterial infection
* Hemoglobin below 8 g/dL
* Neutrophils below 750/mm3
* Platelets below 50,000/mm3
* Creatinine clearance below 60 ml/min
* Alkaline phosphatase, ASAT, ALAT or bilirubin over 3 times the upper limit of normal
```

## Interventions

- **efavirenz** (DRUG) — 800mg for patients treated by rifampicine 600mg for other patients
- **tenofovir DF** (DRUG) — 300mg once a day
- **emtricitabine** (DRUG) — one pill of 200mg once a day

## Primary Outcomes

- **treatment success rate at week 48 (W48)** _(time frame: W48)_

## Secondary Outcomes

- **course of plasma HIV-1 RNA between W0 and W48** _(time frame: W48)_
- **tuberculosis cure rate** _(time frame: W48)_
- **safety of trial treatments (number of events, description, time to onset, metabolic disorders, immune restoration syndrome)** _(time frame: W48)_
- **frequency of treatment changes or discontinuations** _(time frame: W48)_
- **clinical progression of HIV infection** _(time frame: W48)_
- **course of CD4 and CD8 T lymphocytes** _(time frame: W48)_
- **study of resistance in the case of virological failure** _(time frame: W48)_
- **study of compliance and quality of life** _(time frame: W48)_
- **pharmacokinetic study of tuberculostatic agents** _(time frame: W02,W08,W12, W24)_
- **effect of treatment on hepatitis B viral replication** _(time frame: W48)_

## Locations (1)

- Service des maladies Infectieuses et tropicales Hopital Necker-Enfants Malades, Paris, France

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.service des maladies infectieuses et tropicales hopital necker-enfants malades|paris||france` — added _(2026-05-12)_

---

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