This evaluates the effect of lopinavir/ritonavir (LPV/r) on pharmacokinetic parameter AUC of MPA by looking at the MPA AUC from day 0 to week 12. AUC0-12weeks was calculated using single MPA concentrations sampled immediately prior to DMPA administration on day 0, and at 2, 4, 6, 8, 10 and 12 weeks after administration of the single DMPA dose.

One participant was excluded from all PK analyses for taking a prohibited medication with potential to interfere with PK assessments. For another participant who missed week 10 and 12 visits, a modelling approach was used to estimate the week 12 MPA level.

This evaluates the effect of DMPA on LPV PK parameter AUC by comparing PK AUCs of LPV from 0 to 12 hours obtained at study Day 0 (before DMPA was administered) with PK AUCs of LPV from 0 to 12 hours at study Week 4 (4 weeks after DMPA was administered). Blood samples were drawn for LPV concentration levels at time zero (before LPV/r dosing) and at 30 minutes and 1, 2, 3, 4, 5, 6, 8 and 10 hours after LPV/r dosing at day 0 and week 4.

All participants eligible for the first primary PK outcome measure (MPA AUC0-12weeks) were included in this second primary outcome measure looking at LPV AUC0-12hours at Day 0 and week 4.

This evaluates the suppression of ovulation due to the potential PK interaction between DMPA and LPV/r. The LLQ of progesterone is 0.5ng/mL. The threshold for suppression of ovulation is 5ng/mL.

All 24 participants included in the primary analyses were eligible for this secondary objective, however participants occasionally missed the progesterone draw (see N for each week in table below).

This evaluates the effect of LPV/r on the secondary MPA PK parameter Cmin based on MPA levels measured at weeks 0, 2, 4, 6, 8, 10, and 12.

The analysis population is the 24 A5283 participants who took DMPA with LPV/r and were eligible for the primary PK outcome of MPA AUC.

This evaluates the effect of LPV/r on the secondary MPA PK parameter Cmax based on MPA levels measured at weeks 0, 2, 4, 6, 8, 10, and 12.

The analysis population is the 24 A5283 participants who took DMPA with LPV/r and were eligible for the primary PK outcome of MPA AUC.

This evaluates the effect of LPV/r on the secondary MPA PK parameter Tmax based on MPA levels measured at weeks 0, 2, 4, 6, 8, 10, and 12.

The analysis population is the 24 A5283 participants who took DMPA with LPV/r and were eligible for the primary PK outcome of MPA AUC.

This evaluates the effect of LPV/r on the secondary MPA PK parameter CL/F based on MPA levels measured at weeks 0, 2, 4, 6, 8, 10, and 12.

The analysis population is the 24 A5283 participants who took DMPA with LPV/r and were eligible for the primary PK outcome of MPA AUC.

This evaluates the effect of LPV/r on the secondary MPA PK parameter T1/2 based on MPA levels measured at weeks 0, 2, 4, 6, 8, 10, and 12.

The analysis population is the 24 A5283 participants who took DMPA with LPV/r and were eligible for the primary PK outcome of MPA AUC. A minimum of three observations in the elimination phase was required to determine T1/2 and therefore results are presented for 22 participants.

This evaluates the effect of MPA on the secondary LPV PK parameter Cmin obtained from both sampling periods, before DMPA injection at study day 0 and four weeks after DMPA injection at study week 4.

The analysis population is the 24 A5283 participants who took DMPA with LPV/r and were eligible for the primary PK outcome of LPV AUC.

This evaluates the effect of MPA on the secondary LPV PK parameter Cmax obtained from both sampling periods, before DMPA injection at study day 0 and four weeks after DMPA injection at study week 4.

The analysis population is the 24 A5283 participants who took DMPA with LPV/r and were eligible for the primary PK outcome of LPV AUC.

This evaluates the effect of MPA on the secondary LPV PK parameter Tmax obtained from both sampling periods, before DMPA injection at study day 0 and four weeks after DMPA injection at study week 4.

The analysis population is the 24 A5283 participants who took DMPA with LPV/r and were eligible for the primary PK outcome of LPV AUC.

This evaluates the effect of MPA on the secondary LPV PK parameter CL/F obtained from both sampling periods, before DMPA injection at study day 0 and four weeks after DMPA injection at study week 4.

The analysis population is the 24 A5283 participants who took DMPA with LPV/r and were eligible for the primary PK outcome of LPV AUC.

This evaluates the effect of MPA on the secondary LPV PK parameter T1/2 obtained from both sampling periods, before DMPA injection at study day 0 and four weeks after DMPA injection at study week 4.

The analysis population is the 24 A5283 participants who took DMPA with LPV/r and were eligible for the primary PK outcome of LPV AUC.

This evaluates the effect of MPA on the PK parameter AUC0-12h of RTV obtained from both sampling periods, before DMPA injection at study day 0 and after DMPA injection at study week 4. Blood samples were drawn for RTV concentration levels at time zero (before LPV/r dosing) and at 30 minutes and 1, 2, 3, 4, 5, 6, 8 and 10 hours after LPV/r dosing at day 0 and week 4.

The analysis population is the 24 A5283 participants eligible for the primary PK outcome of LPV AUC.

This evaluates the effect of MPA on the PK parameter Cmin of RTV obtained from both sampling periods, before DMPA injection at study day 0 and after DMPA injection at study week 4.

The analysis population is the 24 A5283 participants eligible for the primary PK outcome of LPV AUC.

This evaluates the effect of MPA on the PK parameter Cmax of RTV obtained from both sampling periods, before DMPA injection at study day 0 and after DMPA injection at study week 4.

The analysis population is the 24 A5283 participants eligible for the primary PK outcome of LPV AUC.

This evaluates the effect of MPA on the PK parameter Tmax of RTV obtained from both sampling periods, before DMPA injection at study day 0 and after DMPA injection at study week 4.

The analysis population is the 24 A5283 participants eligible for the primary PK outcome of LPV AUC.

This evaluates the effect of MPA on the PK parameter CL/F of RTV obtained from both sampling periods, before DMPA injection at study day 0 and after DMPA injection at study week 4.

The analysis population is the 24 A5283 participants eligible for the primary PK outcome of LPV AUC.

This evaluates the effect of MPA on the PK parameter T1/2 of RTV obtained from both sampling periods, before DMPA injection at study day 0 and after DMPA injection at study week 4.

The analysis population is the 24 A5283 participants eligible for the primary PK outcome of LPV AUC. For one participant at day 0, T1/2 results were not estimated.

This evaluates toxicity and safety of concomitant medication of DMPA and LPV/r, focusing specifically on the adverse event (AE) menstrual irregularities with abnormal vaginal bleeding. The AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. Relationship to study treatment was determined by the study's co-chairs.

This analysis focuses on the 24 participants eligible for the PK analyses.

This evaluates the short-term impact of MPA on virologic suppression in participants taking LPV/r who have received a dose of DMPA by measuring percentage of participants with HIV-1 RNA levels <400 copies/mL at day 0 (prior to DMPA injection) and at weeks 2, 4, 8 and 12 (after DMPA injection). An FDA-approved HIV-1 RNA assay with a lower limit of detection of 75 copies/mL or less was required and the same HIV-1 RNA assay was required to be performed for each participant across all study visits. The Roche COBAS AmpliPrep/TaqMan HIV-1 and Abbott RealTime HIV-1 tests were used.

All 24 participants included in the primary analyses were eligible for this secondary objective, however participants occasionally missed the HIV-1 RNA draw (see N for each week in table below).

This evaluates the effect of MPA on CMI to HIV and VZV at baseline before DMPA (day 0) and after DMPA (weeks 4 and 12) . Cytokines are interferon-gamma (IFN-gamma) and interleukin 2 (IL-2), and Stimuli are HIV and VZV. Summary of adjusted ELISPOT assay results is in spot forming cells (SFC)/10^6 peripheral blood mononuclear cells (PBMC) by study weeks 0, 4 and 12. The outcome measures of IFN-gamma and IL-2 measured for HIV and VZV are presented here together to provide all results pertaining to the same objective in a single data table.

All 24 participants included in the primary analyses were eligible for this secondary objective. 22 participants with available data were analyzed.

This evaluates the effect of MPA on CMI to HIV and VZV. This outcome was measured at Baseline Before DMPA (Day 0) and After DMPA (Weeks 4 and 12) using the Lymphocyte Proliferation Assay (LPA). The data table shows a summary of LPA assay results by study week with stimuli HIV and VZV. Proliferation results are reported as a stimulation index (SI) which represents the ratio of the stimulated counts per minute to unstimulated control counts per minute.

All 24 participants included in the primary analyses were eligible for this secondary objective. 22 participants with available data were analyzed.

This evaluates the effect of MPA on Tregs at baseline (Day 0), week 4 and week 12 using flow cytometry in freshly thawed PBMCs. A summary of CD4+ and cluster of differentiation 8 (CD8+) anchored T-cell subsets by study week, in percent that express the marker of interest, is presented here together to provide all results pertaining to this objective in a single data table.

All 24 participants included in the primary analyses were eligible for this secondary objective. 21 participants with available data were analyzed.