NCT00144183|CompletedPhase 3

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

An Open-label Study Evaluating the Resistance Profile of Single Dose Nevirapine(NVP) When Combined With a 4 or 7 Day Course of Combivir® (ZDV/3TC) Compared to Single Dose Nevirapine for the Prevention of Mother to Child Transmission (pMTCT) of HIV - Treatment Options Preservation Study (T.O.P.S.)

Boehringer Ingelheim ClinicalTrials.gov

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2 other identifiers

1100.1413MCC;N2/19/8/2(1958)

Study Type

interventional

Target

407

Locations

1 country

Sites

Timeline

RegisteredSep 2005

StartedJan 2003

CompletionJan 2007

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 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

407

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Jan 2003

Typical duration for phase_3

Geographic Reach

1 country

5 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4 years study duration

Study Start

First participant enrolled

January 1, 2003

Completed

2.7 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2005

Completed

3 days until next milestone

First Posted

Study publicly available on registry

September 5, 2005

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed

Last Updated

November 4, 2013

Status Verified

November 1, 2013

Enrollment Period

4 years

First QC Date

September 2, 2005

Last Update Submit

November 1, 2013

Conditions

Acquired Immunodeficiency Syndrome

Outcome Measures

Primary Outcomes (1)

Percentage of mothers with HIV-1 isolates with new NNRTI (Non Nucleoside Reverse Transcriptase Inhibitor) resistance-associated mutations identified by genotype testing
6 weeks following delivery

Interventions

Nevirapine (NVP)DRUG

Nevirapine 200mg once daily for 14 days followed by 200mg twice daily thereafter for the remainder of the treatment period. Combivir®, one tablet twice daily.

Zidovudine (ZCV)DRUG

3TCDRUG

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.