Acquired Immunodeficiency SyndromePhase 4NCT00144157
Open Label Study of NVP+CBV Treatment in Women Who Have Received sdNVP for the pMTCT of HIV
A Phase 4 study testing Nevirapine, Zidovudine and 3TC in people with Acquired Immunodeficiency Syndrome, run by Boehringer Ingelheim at 3 sites in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 45 years, women only
- Conditions the study is for
- Acquired Immunodeficiency Syndrome
- What is being tested?
- Nevirapine, Zidovudine and 3TC
- How many people
- 53 participants
- Where
- 3 sitesSouth Africa
- Study dates
- Jun 2003to Jul 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
South Africa3 sites
Boehringer Ingelheim Investigational Site
Capetown, 7925
Boehringer Ingelheim Investigational Site
Parow, 7505
Boehringer Ingelheim Investigational Site
Soweto, 2013
About this study
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.
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.
Read the 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
- Conditions
- Acquired Immunodeficiency Syndrome
- Being tested
- Nevirapine, Zidovudine, 3TC
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NevirapineDrug
ZidovudineDrug
3TCDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (1)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startJun 2003
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Immunodeficiency SyndromeStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim Study Coordinator, Study chair, B.I. South Africa (Pty.) Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00144157
- Sponsor's protocol ID
- 1100.1414
- Status last verified
- Nov 2013
- First submitted
- 2 Sep 2005
- Last updated
- 14 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00144157
- Acronym / sponsor ID
- 1100.1414
- Conditions
- Acquired Immunodeficiency Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jun 2003
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006
- First posted
- 5 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nevirapine | Drug | – |
| Zidovudine | Drug | – |
| 3TC | Drug | – |
Primary outcome
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 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2013.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim Study Coordinator study chair
B.I. South Africa (Pty.) Ltd.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nevirapine, Zidovudine and 3TC in people with Acquired Immunodeficiency Syndrome, run by Boehringer Ingelheim at 3 sites in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2013.