Phase 4
N=54
HIV Treatment Reinitiation in Women Who Received Anti-HIV Drugs to Prevent Mother-to-Child Transmission of HIV
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT00442962 ↗Enrolled (actual)
54
Serious AEs
1.8%
Results posted
Aug 2011
Primary outcome: Primary: Percentage of Participants With Early Virologic Response — 80.8 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Efavirenz (Drug); Emtricitabine/Tenofovir disoproxil fumarate (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- Female
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Early Virologic Response |
80.8 | — |
| SECONDARY Time to First Safety Event |
4.1; 24.4; 33.1 | — |
| SECONDARY Percentage of Participants With Early Virologic Suppression |
72.0 | — |
| SECONDARY Percentage of Participants With Late Virologic Response |
80.43 | — |
| SECONDARY Time to Initial Virologic Response |
2; 8; 24 | — |
| SECONDARY Time to Initial Virological Failure |
16; 16; 24 | — |
| SECONDARY Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm) |
16; 24; 24 | — |
| SECONDARY Early Changes in CD4 Count From Baseline |
105; 118; 138; 147 | — |
| SECONDARY Percentage of Participants With Late Virologic Suppression |
70.5 | — |
| SECONDARY Time to First Dose Modification |
1.9; 24.9; 25.7 | — |
| SECONDARY Late Change in CD4 Count From Baseline |
194 | — |
Summary
The purpose of this study is to determine if pregnancy-limited, short-term combination HIV treatment regimens -- which were used solely for the prevention of mother to child transmission of HIV and discontinued postpartum -- decreases the effectiveness of a standard initial regimen of anti-HIV drugs when subsequent treatment is needed.
Eligibility Criteria
Inclusion Criteria
- HIV-1 infected
- Viral load of 500 copies/mL or more
- Prior HAART for more than 7 days, but less than 40 weeks during at least one previous pregnancy for prevention of MTCT of HIV
- Clinical or laboratory indication to start HAART, in the opinion of the participant's physician
- Certain laboratory values
- Willingness to use acceptable forms of contraception
- Parent or guardian willing to provide informed consent, if applicable
Exclusion Criteria
- Taking any antiretroviral medication within 24 weeks prior to study entry
- Evidence of certain HIV-1 RT mutations within 90 days prior to study entry (version 1.0)
- Evidence of certain HIV-1 RT mutations identified by standard bulk viral population genotypic resistance tests at any time prior to study entry, if available (version 2.0, 09/03/2009)
- Treatment at any time, for any reason with nevirapine as a single agent OR addition of any part of the study regimen as a single agent to a failing regimen
- Use of certain antihistamines, certain anti-infectives, cisapride, St John's wort, midazolam, triazolam, dihydroergotamine, ergonovine, ergotamine, or methylergonovine within 14 days prior to study entry
- Use of HIV vaccine, chronic systemic corticosteroids, interleukins, interferons, other cytokines, or investigational therapy within 30 days prior to study entry
- Acute or chronic therapy for certain serious medical illnesses within 14 days of study entry. Participants who have completed 7 days of therapy and are judged clinically stable are not excluded.
- Cancer requiring systemic chemotherapy
- Known allergy/sensitivity to the study drugs or their formulations
- Current drug or alcohol use that, in the opinion of the investigator, would interfere with the study
- Two consecutive HIV viral loads of more than 5,000 copies/mL 8 weeks or more following initiation of HAART during pregnancy and while still receiving HAART
- Two consecutive viral loads of more than 400 copies/mL 24 weeks or more following initiation of HAART during pregnancy while still receiving HAART
- Current imprisonment or involuntary incarceration in a medical facility for psychiatric or physical illness
- Pregnancy or breastfeeding
Data sourced from ClinicalTrials.gov (NCT00442962). 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.