Open Label Study of NVP+CBV Treatment in Women Who Have Received sdNVP for the pMTCT of HIV

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

South Africa

Study Type

Interventional

Intervention

Nevirapine

Zidovudine

3TC

About this trial

This is an interventional treatment trial for Acquired Immunodeficiency Syndrome

Eligibility Criteria

19 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

INCLUSION CRITERIA HIV-1-infected non-pregnant women who received a nevirapine regimen, for the prevention of mother to child transmission, at least 12 months previously. Women of child-bearing potential must have a negative urine pregnancy test at the screening visit and ensure double barrier methods of contraception, which by definition will in all cases include the use of condoms, throughout the study period. CD4 cell count < 350 cells/mm3 and viral load HIV-1 RNA > 20,000 c/mL or any symptomatic individual (WHO stage 3) or the presence of any AIDS defining criteria. Documented HIV-1 positive status by a licensed HIV-1 ELISA test. EXCLUSION CRITERIA Women who are pregnant or breastfeeding. Women with prior exposure to antiretroviral therapy, other than a nevirapine regimen for the prevention of mother to child transmission at least 12 months previously. Subjects who in the investigator's opinion are unlikely to complete the 48 week study period or unlikely to comply with the dosing schedule and protocol evaluations. Patients with a Karnofsky performance status score < 70. Subjects who fail to meet the HIV treatment criteria (CD4 and viral load) indicated above.

Sites / Locations

Boehringer Ingelheim Investigational Site
Boehringer Ingelheim Investigational Site
Boehringer Ingelheim Investigational Site

Outcomes

Primary Outcome Measures

The proportion of patients who fail to suppress viral load to 400c/mL or maintain a viral load 400 c/mL at 24 and 48 weeks. The mean change in HIV RNA measurement by 24 weeks.

Secondary Outcome Measures

What type of resistance that develops Immunologic response to treatment Treatment safety Time to treatment and/or virologic failure 5.How many achieve viral loads<50c/mL

Full Information

NCT ID

NCT00144157

First Posted

September 2, 2005

Last Updated

November 13, 2013

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT00144157

Brief Title

Open Label Study of NVP+CBV Treatment in Women Who Have Received sdNVP for the pMTCT of HIV

Official Title

An Open-Label Study of Nevirapine Plus Combivir® (ZDV+3TC) Treatment in Women Who Have Previously Received a Nevirapine Regimen for the Prevention of Mother to Child Transmission (pMTCT) of HIV-1.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Completed

Study Start Date

June 2003 (undefined)

Primary Completion Date

July 2006 (Actual)

Study Completion Date

July 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary

To determine the response to treatment with NVP, ZDV and 3TC in HIV positive women, who previously received NVP for the prevention of mother to child transmission.

Detailed Description

An open-label, single arm, multicentre study to determine the virologic and immunologic responsiveness of women, who previously received a regimen of nevirapine for the prevention of MTCT, to a regimen of nevirapine and ZDV+3TC treatment. As well as to evaluate the proportion of patients who fail this treatment at 24 and 48 weeks, and to evaluate the resistance profile of HIV isolates from patients who fail nevirapine and ZDV+3TC treatment. Study Hypothesis: When a drug leading to selection of a resistant viral population is withdrawn the original wildtype virus, over time, becomes the predominant virus again. However, low frequency (below level of detection) of drug resistant viral sub-populations may be retained which could mean that the drug resistant variant might reappear rapidly should the same drug be reintroduced as part of combination therapy at a later stage.Therefore this study is proposed to evaluate whether there is an impact of single dose nevirapine for the prevention of MTCT on the subsequent response to a standard HAART regimen that contains nevirapine. Comparison(s): trial 1100.1090

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acquired Immunodeficiency Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

53 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Nevirapine

Intervention Type

Drug

Intervention Name(s)

Zidovudine

Intervention Type

Drug

Intervention Name(s)

3TC

Primary Outcome Measure Information:

Title

The proportion of patients who fail to suppress viral load to 400c/mL or maintain a viral load 400 c/mL at 24 and 48 weeks. The mean change in HIV RNA measurement by 24 weeks.

Secondary Outcome Measure Information:

Title

What type of resistance that develops Immunologic response to treatment Treatment safety Time to treatment and/or virologic failure 5.How many achieve viral loads<50c/mL

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

INCLUSION CRITERIA HIV-1-infected non-pregnant women who received a nevirapine regimen, for the prevention of mother to child transmission, at least 12 months previously. Women of child-bearing potential must have a negative urine pregnancy test at the screening visit and ensure double barrier methods of contraception, which by definition will in all cases include the use of condoms, throughout the study period. CD4 cell count < 350 cells/mm3 and viral load HIV-1 RNA > 20,000 c/mL or any symptomatic individual (WHO stage 3) or the presence of any AIDS defining criteria. Documented HIV-1 positive status by a licensed HIV-1 ELISA test. EXCLUSION CRITERIA Women who are pregnant or breastfeeding. Women with prior exposure to antiretroviral therapy, other than a nevirapine regimen for the prevention of mother to child transmission at least 12 months previously. Subjects who in the investigator's opinion are unlikely to complete the 48 week study period or unlikely to comply with the dosing schedule and protocol evaluations. Patients with a Karnofsky performance status score < 70. Subjects who fail to meet the HIV treatment criteria (CD4 and viral load) indicated above.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Boehringer Ingelheim Study Coordinator

Organizational Affiliation

B.I. South Africa (Pty.) Ltd.

Official's Role

Study Chair

Facility Information:

Facility Name

Boehringer Ingelheim Investigational Site

City

Capetown

ZIP/Postal Code

7925

Country

South Africa

Facility Name

Boehringer Ingelheim Investigational Site

City

Parow

ZIP/Postal Code

7505

Country

South Africa

Facility Name

Boehringer Ingelheim Investigational Site

City

Soweto

ZIP/Postal Code

2013

Country

South Africa

12. IPD Sharing Statement

Links:

URL

http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1100/1100.1414.pdf

Description

Related Info

Acquired Immunodeficiency Syndrome

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial