Phase 3
N=741
NNRTI vs PI Regimens for HIV Infected Women After They Have Taken Nevirapine to Prevent Mother-To-Child HIV Transmission
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT00089505 ↗Enrolled (actual)
741
Serious AEs
8.1%
Results posted
Feb 2011
Primary outcome: Primary: Time From Randomization to Virologic Failure or Death for Participants Who Had SD NVP Exposure Prior to Study Entry — 12; 60; 12; 84 weeks — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Emtricitabine (Drug); Emtricitabine/Tenofovir disoproxil fumarate (Drug); Lopinavir/Ritonavir (Drug); Nevirapine (Drug); Tenofovir disoproxil fumarate (Drug)
- Age
- Pediatric, Adult, Older Adult · 13+ yrs
- Sex
- Female
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time From Randomization to Virologic Failure or Death for Participants Who Had SD NVP Exposure Prior to Study Entry |
12; 60; 12; 84; 60; NA | <0.001 sig |
| PRIMARY Time From Randomization to Virologic Failure or Death for Participants Without SD NVP Exposure Prior to Study Entry |
24; 12; 36; 36; NA; 132 | 0.43 |
| SECONDARY Number of Participants Who Experienced Virologic Failure or Died. |
32; 10; 42; 50 | — |
| SECONDARY Percent of Participants Who Experienced Virologic Failure or Died |
23; 4; 14; 14; 31; 12 | — |
| SECONDARY CD4 Count Change From Randomization |
191; 201; 172; 172; 291; 278 | — |
| SECONDARY Number of Participants Who Experienced Treatment-related Toxicity That Led to Discontinuation of Randomized Regimen. |
15; 0; 35; 0 | — |
| SECONDARY Number of Participants Who Experienced HIV-related Disease Progression or Death |
6; 4; 19; 26 | — |
| SECONDARY Number of Participants Who Received NVP-containing Regimens at Randomization and Experienced NVP-associated Rash or Grade 2+ Liver Lab Abnormality |
20; 51 | — |
| SECONDARY Percent of Participants Who Reported to Never Missed Any of the Study Drug Regimen in the Past Month |
89; 88; 90; 86; 94; 95 | — |
Summary
Non-nucleoside reverse transcriptase inhibitors (NNRTIs) are commonly included in anti-HIV drug regimens. However, HIV infected women who have previously taken the single dose NNRTI nevirapine (SD NVP) for the prevention of mother-to-child transmission (MTCT) of HIV may not respond as well to NNRTIs as women who have never taken NVP. Another class of anti-HIV drugs, protease inhibitors (PIs), may be more effective for women who have previously taken NNRTIs. This study will compare the effectiveness of NNRTI- and PI-based regimens in women who have taken NVP for prevention of MTCT of HIV. This study will also compare regimens including an NNRTI with regimens including a PI in women who have never taken NVP.
Eligibility Criteria
Inclusion Criteria for All Participants:
- HIV infected
- CD4 count less than 200 cells/mm^3 within 90 days prior to study entry
- Plasma HIV-1 RNA using standard Roche Amplicor HIV-1 Monitor Assay within 45 days prior to study entry
- the following laboratory values obtained within 45 days prior to study entry: absolute neutrophil count>=750/mm^3;Hemoglobin>=7.0g/dL;platelet count>=50000/mm^3;aspartate aminotransferase (AST),Alanine aminotransferase (ALT), and alkaline phosphatase =70 on at least one occasion within 45 days prior to study entry
- Parent or guardian willing to provide informed consent, if applicable
- Planning to remain in the same geographical area of residence and are willing to attend study visits as required
Inclusion Criteria for Trial 1 Participants:
- Previously received NVP for prevention of MTCT of HIV
- Has documentation of all prior doses of NVP used for prevention of MTCT of HIV
- Last dose of NVP for prevention of MTCT of HIV taken at least 6 months prior to study entry
Exclusion Criteria for All Participants:
- Previously received any antiretrovirals, excluding NVP for MTCT prophylaxis for Trial 1 participants. Participants who have received up to 10 weeks of zidovudine alone and completed this course at least 6 months prior to study entry are not excluded.
- Use of systemic cancer chemotherapy, systemic investigational agents, immunomodulators, or rifampin within 30 days of study entry
- Pregnant or breastfeeding
- Known allergy or sensitivity to study drugs or their formulations
- Any condition, including drug or alcohol abuse, that, in the opinion of the investigator, may interfere with adherence to study regimens
- Serious illness requiring systemic treatment or hospitalization. Participants who complete therapy or are clinically stable on therapy for at least 30 days prior to study entry are not excluded.
- Tuberculosis (TB) treatment within 30 days prior to study entry
- Use of any prohibited medications within 30 days prior to study entry
- Involuntary incarceration in a correctional facility, prison, or jail for legal reasons or in a medical facility for treatment of either a psychiatric or physical illness
Data sourced from ClinicalTrials.gov (NCT00089505). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.