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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00144157
First received: September 2, 2005
Last updated: November 13, 2013
Last verified: November 2013

September 2, 2005
November 13, 2013
June 2003
July 2006   (final data collection date for primary outcome measure)
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.
  • 1. 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.
  • 2. The mean change in HIV RNA measurement by 24 weeks.
Complete list of historical versions of study NCT00144157 on ClinicalTrials.gov Archive Site
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
  • 1.what type of resistance that develops
  • 2. Immunologic response to treatment
  • 3.Treatment safety
  • 4.Time to treatment and/or virologic failure
  • 5.How many achieve viral loads<50c/mL
Not Provided
Not Provided
 
Open Label Study of NVP+CBV Treatment in Women Who Have Received sdNVP for the pMTCT of HIV
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.

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.

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When a drug leading to selection of a resistant viral population is withdrawn the original wildtype virus, over time, becomes the predominant virus again.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

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Acquired Immunodeficiency Syndrome
  • Drug: Nevirapine
  • Drug: Zidovudine
  • Drug: 3TC
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
July 2006
July 2006   (final data collection date for primary outcome measure)

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.
Female
19 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
South Africa
 
NCT00144157
1100.1414
Not Provided
Not Provided
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Study Coordinator B.I. South Africa (Pty.) Ltd.
Boehringer Ingelheim
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP