Trial Outcomes & Findings for Influence of Antiretroviral Regimen on Immune Reconstitution in the Female Genital Tract (NCT NCT01456962)

Results Overview

Evaluation of cervical immune health in HIV-infected women on tenofovir (TDF) and emtricitabine (FTC) and either raltegravir or atazanavir. Cervical CD4+ to CD8+ T cell ratios will be measured at one time point from cervical biopsies. Higher ratios will be a measure of better cervical immune health. In addition, ratios will be compared to the concentration of the drug in the genital tract.

Recruitment status

COMPLETED

Target enrollment

36 participants

Primary outcome timeframe

12 hours after the last medication dose

Results posted on

2017-06-09

Participant Flow

Participant milestones

Participant milestones
Measure	Raltegravir Group HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with raltegravir (RAL) with a CD4+ T-cells/mm3 \>300 and HIV RNA copies/mL \<48 for a minimum of 6 months.	Atazanavir Group HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with ritonavir (RIT)-boosted atazanavir (ATZ) with a CD4+ T-cells/mm3 \>300 and HIV RNA copies/mL \<48 for a minimum of 6 months.
Overall Study STARTED	16	20
Overall Study COMPLETED	14	19
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Raltegravir Group HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with raltegravir (RAL) with a CD4+ T-cells/mm3 \>300 and HIV RNA copies/mL \<48 for a minimum of 6 months.	Atazanavir Group HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with ritonavir (RIT)-boosted atazanavir (ATZ) with a CD4+ T-cells/mm3 \>300 and HIV RNA copies/mL \<48 for a minimum of 6 months.
Overall Study Lost to Follow-up	2	1

Baseline Characteristics

Influence of Antiretroviral Regimen on Immune Reconstitution in the Female Genital Tract

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Raltegravir Group n=14 Participants HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with raltegravir (RAL) with a CD4+ T-cells/mm3 \>300 and HIV RNA copies/mL \<48 for a minimum of 6 months.	Atazanavir Group n=19 Participants HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with ritonavir (RIT)-boosted atazanavir (ATZ) with a CD4+ T-cells/mm3 \>300 and HIV RNA copies/mL \<48 for a minimum of 6 months.	Total n=33 Participants Total of all reporting groups
Age, Continuous	44 years n=5 Participants	43 years n=7 Participants	43 years n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	19 Participants n=7 Participants	33 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants	19 participants n=7 Participants	33 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 hours after the last medication dose

Evaluation of cervical immune health in HIV-infected women on tenofovir (TDF) and emtricitabine (FTC) and either raltegravir or atazanavir. Cervical CD4+ to CD8+ T cell ratios will be measured at one time point from cervical biopsies. Higher ratios will be a measure of better cervical immune health. In addition, ratios will be compared to the concentration of the drug in the genital tract.

Outcome measures

Outcome measures
Measure	Raltegravir Group n=14 Participants HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with raltegravir (RAL)	Atazanavir Group n=19 Participants HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with ritonavir (RIT)-boosted atazanavir (ATZ)
CD4+ to CD8+ T Cell Ratio in Cervical Biopsies	0.46 Cervical CD4+:CD8+ T cell ratio Interval 0.33 to 0.63	0.52 Cervical CD4+:CD8+ T cell ratio Interval 0.36 to 0.75

Adverse Events

Raltegravir Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Atazanavir Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Peter Anderson, Pharm D

University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences

Phone: 303-724-6128

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place