Acquired Immunodeficiency Syndrome Clinical Trial
Official title:
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.)
Verified date | November 2013 |
Source | Boehringer Ingelheim |
Contact | n/a |
Is FDA regulated | No |
Health authority | South Africa: Medicines Control Council |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 407 |
Est. completion date | January 2007 |
Est. primary completion date | January 2007 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
South Africa | Boehringer Ingelheim Investigational Site | Attridgeville | |
South Africa | Boehringer Ingelheim Investigational Site | Cape Town | |
South Africa | Boehringer Ingelheim Investigational Site | Durban | |
South Africa | Boehringer Ingelheim Investigational Site | Johannesburg | |
South Africa | Boehringer Ingelheim Investigational Site | Soweto |
Lead Sponsor | Collaborator |
---|---|
Boehringer Ingelheim |
South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
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