Status:
COMPLETED
A Study of Single Dose Nevirapine (NVP) Combined With Combivir® for the Prevention of Mother to Child Transmission (pMTCT) - Treatment Options Preservation Study (TOPS)
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Acquired Immunodeficiency Syndrome
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
To determine whether a regimen of single dose nevirapine combined with either 4 or 7 days of Combivir®, compared to a regimen of single dose nevirapine, for the prevention of mother to child transmiss...
Detailed Description
An open-label, randomised, multicentre study to determine whether a regimen of single dose nevirapine combined with either 4 or 7 days of Combivir, compared to a regimen of single dose nevirapine, for...
Eligibility Criteria
Inclusion
- Pregnant women identified at antenatal clinics after from 34 weeks gestation and who are antiretroviral drug naive.
- Mothers with a documented positive HIV Rapid test confirmed by a detectable HI V-1 RNA PCR (viral load).
- Mother to have a screening viral load of \> 2000 RNA copies/mL.
Exclusion
- Mothers who, in the opinion of the investigator ,cannot be relied on to return with their infants for postnatal visits.
- Mothers who have received any antiretroviral drugs previously.
- Clinical suspicion of intra-uterine foetal death
- Unwillingness or inability to reasonably comply with the protocol requirements.
- Use of any other investigational product during the pregnancy and for the dura tion of the study period.
- Patients with a recent history of pancreatitis or peripheral neuropathy.
- Patients with renal failure requiring dialysis.
- Patients with evidence of hepatic dysfunction as measured by total bilirubin \> 2.5 times ULN or AST/ALT \> 5 times ULN at the screening visit.
- Patients with any one of the following additional laboratory abnormalities at screening : Haemoglobin concentration \< 7.5 g/dl. Neutrophil count \< 750 cells/mm3. Platelet count \< 75,000 cells/mm3. Serum amylase \> 2 x ULN.
- recent history ( during the pregnancy) of drug abuse or alcoholism.
- Mothers who will undergo elective caesarean section.
- If known prior to delivery, mothers with foetuses with anomalies incompatible with life.
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
End Date :
January 1 2007
Estimated Enrollment :
407 Patients enrolled
Trial Details
Trial ID
NCT00144183
Start Date
January 1 2003
End Date
January 1 2007
Last Update
November 4 2013
Active Locations (5)
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1
Boehringer Ingelheim Investigational Site
Attridgeville, South Africa, 0081
2
Boehringer Ingelheim Investigational Site
Cape Town, South Africa, 7505
3
Boehringer Ingelheim Investigational Site
Durban, South Africa, 4001
4
Boehringer Ingelheim Investigational Site
Johannesburg, South Africa, 2093