Overview

A Study of Single Dose Nevirapine (NVP) Combined With Combivir® for the Prevention of Mother to Child Transmission (pMTCT) - Treatment Options Preservation Study (TOPS)

Status:
Completed
Trial end date:
2007-01-01
Target enrollment:
0
Participant gender:
Female
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 transmission can reduce the rate of development of drug resistant mutations of HIV-1, in HIV-1 infected pregnant women, who have not received antiretroviral therapy previously.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Boehringer Ingelheim
Treatments:
Lamivudine, zidovudine drug combination
Nevirapine
Zidovudine
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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.