NNRTI vs PI Regimens for HIV Infected Women After They Have Taken Nevirapine to Prevent Mother-To-Child HIV Transmission (OCTANE)

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
AIDS Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00089505
First received: August 5, 2004
Last updated: May 10, 2011
Last verified: May 2011
Results First Received: August 30, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: Emtricitabine
Drug: Emtricitabine/Tenofovir disoproxil fumarate
Drug: Lopinavir/Ritonavir
Drug: Nevirapine
Drug: Tenofovir disoproxil fumarate

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study participants were recruited at 10 sites from 7 African countries: 3 from South Africa, 2 from Kenya, and 1 each in Botswana, Malawi, Uganda, Zambia and Zimbabwe, between November 2006 to July 2008. The Botswana site enrolled participants from two locations.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
HIV-infected, treatment-naive women, at least 13 years of age with CD4+ count<200 cells/mm^3. Four participants were randomized but did not start treatment.

Reporting Groups
  Description
NVP/NVP For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
NVP/LPV_r For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
NoNVP/NVP For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
NoNVP/LPV_r For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.

Participant Flow:   Overall Study
    NVP/NVP     NVP/LPV_r     NoNVP/NVP     NoNVP/LPV_r  
STARTED     121 [1]   120     249 [1]   251  
COMPLETED     112 [2]   118 [3]   228     230  
NOT COMPLETED     9     2     21     21  
Death                 4                 1                 5                 8  
Withdrawal by Subject                 3                 0                 6                 6  
Lost to Follow-up                 1                 1                 9                 7  
Physician Decision                 1                 0                 0                 0  
Protocol Violation                 0                 0                 1                 0  
[1] 2 women never started treatment and per protocol, were not followed and not included in analysis.
[2] The results for NVP/NVP were through database cutoff for DSMB review (by 6 October 2008).
[3] The results for NVP/LPV_r were through database cutoff for DSMB review (by 6 October 2008).



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Time From Randomization to Virologic Failure or Death for Participants Who Had SD NVP Exposure Prior to Study Entry   [ Time Frame: Through database cutoff for DSMB review (by October 6, 2008) with median follow-up 72 weeks and range from 0 to 144 weeks. ]

2.  Primary:   Time From Randomization to Virologic Failure or Death for Participants Without SD NVP Exposure Prior to Study Entry   [ Time Frame: Throughout study with median follow-up 72 weeks and range from 0 to 180 weeks. ]

3.  Secondary:   Number of Participants Who Experienced Virologic Failure or Died.   [ Time Frame: Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r. ]

4.  Secondary:   Percent of Participants Who Experienced Virologic Failure or Died   [ Time Frame: Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r arms. Throughout study for NoNVP/NVP and NoNVP/LPV_r arms. ]

5.  Secondary:   CD4 Count Change From Randomization   [ Time Frame: Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r. Week 48 and 96. ]

6.  Secondary:   Number of Participants Who Experienced Treatment-related Toxicity That Led to Discontinuation of Randomized Regimen.   [ Time Frame: Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r. ]

7.  Secondary:   Number of Participants Who Experienced HIV-related Disease Progression or Death   [ Time Frame: Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r. ]

8.  Secondary:   Number of Participants Who Received NVP-containing Regimens at Randomization and Experienced NVP-associated Rash or Grade 2+ Liver Lab Abnormality   [ Time Frame: Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP arm. Throughout study for NoNVP/NVP arm. ]

9.  Secondary:   Percent of Participants Who Reported to Never Missed Any of the Study Drug Regimen in the Past Month   [ Time Frame: Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r arms. Throughout study for NoNVP/NVP and NoNVP/LPV_r arms. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information