Open Label Study of NVP+CBV Treatment in Women Who Have Received sdNVP for the pMTCT of HIV
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| ClinicalTrials.gov Identifier: NCT00144157 |
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Recruitment Status
:
Completed
First Posted
: September 5, 2005
Last Update Posted
: November 14, 2013
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Acquired Immunodeficiency Syndrome | Drug: Nevirapine Drug: Zidovudine Drug: 3TC | Phase 4 |
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When a drug leading to selection of a resistant viral population is withdrawn the original wildtype virus, over time, becomes the predominant virus again.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
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 53 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 Start Date : | June 2003 |
| Actual Primary Completion Date : | July 2006 |
| Study Completion Date : | July 2006 |
- 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.
- 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
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| Ages Eligible for Study: | 19 Years to 45 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00144157
| South Africa | |
| Boehringer Ingelheim Investigational Site | |
| Capetown, South Africa, 7925 | |
| Boehringer Ingelheim Investigational Site | |
| Parow, South Africa, 7505 | |
| Boehringer Ingelheim Investigational Site | |
| Soweto, South Africa, 2013 | |
| Study Chair: | Boehringer Ingelheim Study Coordinator | B.I. South Africa (Pty.) Ltd. |
| ClinicalTrials.gov Identifier: | NCT00144157 History of Changes |
| Other Study ID Numbers: |
1100.1414 |
| First Posted: | September 5, 2005 Key Record Dates |
| Last Update Posted: | November 14, 2013 |
| Last Verified: | November 2013 |
Additional relevant MeSH terms:
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Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome HIV Infections Immune System Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Zidovudine |
Nevirapine Antimetabolites Molecular Mechanisms of Pharmacological Action Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents Cytochrome P-450 CYP3A Inducers Cytochrome P-450 Enzyme Inducers |