Page last updated: 2024-11-07
lynestrenol and HIV Coinfection
lynestrenol has been researched along with HIV Coinfection in 1 studies
Lynestrenol: A synthetic progestational hormone used often in mixtures with estrogens as an oral contraceptive (CONTRACEPTIVES, ORAL).
Research Excerpts
| Excerpt | Relevance | Reference |
|---|
| "We did a parallel, three-group, pharmacokinetic evaluation at HIV clinics in Asia (two sites), South America (five), sub-Saharan Africa (three), and the USA (11) between Dec 30, 2014, and Sept 12, 2016." | 1.51 | Antiretroviral therapy and vaginally administered contraceptive hormones: a three-arm, pharmacokinetic study. ( Akelo, V; Aweeka, F; Aziz, M; Berzins, B; Cohn, SE; Coombs, RW; Coughlin, K; Cramer, YS; Friedman, RK; Gingrich, D; Godfrey, C; Moran, LE; Rosenkranz, SL; Scarsi, KK; Swaminathan, S; Zorrilla, CD, 2019) |
Research
Studies (1)
| Timeframe | Studies, this research(%) | All Research% |
|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 0 (0.00) | 29.6817 |
| 2010's | 1 (100.00) | 24.3611 |
| 2020's | 0 (0.00) | 2.80 |
Authors
| Authors | Studies |
|---|
| Scarsi, KK | 1 |
| Cramer, YS | 1 |
| Rosenkranz, SL | 1 |
| Aweeka, F | 1 |
| Berzins, B | 1 |
| Coombs, RW | 1 |
| Coughlin, K | 1 |
| Moran, LE | 1 |
| Zorrilla, CD | 1 |
| Akelo, V | 1 |
| Aziz, M | 1 |
| Friedman, RK | 1 |
| Gingrich, D | 1 |
| Swaminathan, S | 1 |
| Godfrey, C | 1 |
| Cohn, SE | 1 |
Clinical Trials (1)
Trial Overview
| Trial | Phase | Enrollment | Study Type | Start Date | Status |
|---|
| Evaluating Pharmacokinetic Interactions With Vaginal Ring Contraceptives and Antiretroviral Therapy (ART)[NCT01903031] | Phase 2 | 84 participants (Actual) | Interventional | 2014-12-30 | Completed |
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] |
Trial Outcomes
Ethinyl Estradiol Concentrations at Study Day 21
This evaluates the effect of EFV and ATV/r on ethinyl estradiol by measuring ethinyl estradiol concentrations on all three study arms 21 days after NuvaRing administration. The PK blood sample for measurement of ethinyl estradiol on study day 21 was taken before the NuvaRing was removed. The assay lower limit of quantification for ethinyl estradiol was 5 pg/mL ; values < 5 were assigned a value of half the lower limit (ie, 2.5 pg/mL). (NCT01903031)
Timeframe: Day 21
| Intervention | pg/mL (Median) |
|---|
| NuvaRing and no ART | 21.30 |
| NuvaRing With EFV Plus ≥2 NRTIs | 11.40 |
| NuvaRing With ATV/r Plus TDF and ≥1 NRTIs | 16.05 |
Etonogestrel Concentrations at Study Day 21
This evaluates the effect of EFV and ATV/r on etonogestrel by measuring etonogestrel concentrations on all three study arms 21 days after NuvaRing administration. The pharmacokinetic (PK) blood sample for measurement of etonogestrel on study day 21 was taken before the NuvaRing was removed. The assay lower limit of quantification for etonogestrel was 250 pg/mL; values < 250 were assigned a value of half the lower limit (ie, 125 pg/mL). (NCT01903031)
Timeframe: Day 21
| Intervention | pg/mL (Median) |
|---|
| NuvaRing and no ART | 1860.00 |
| NuvaRing With EFV Plus ≥2 NRTIs | 429.00 |
| NuvaRing With ATV/r Plus TDF and ≥1 NRTIs | 3290.00 |
Percentage of Participants With Signs and Symptoms of Grade 2 or Higher Deemed Possibly, Probably or Definitely Related to Study Treatment
This evaluates toxicity and safety of NuvaRing alone, NuvaRing with EFV, and NuvaRing with ATV/r. Signs/symptoms were graded using the DAIDS AE Grading Table was used. Participants with sign(s)/symptom(s) of grade 2 (moderate), 3 (severe), 4 (potentially life-threatening) or 5 (death) are included in the percentage. Relationship to study treatment was determined by the study co-chairs and DAIDS clinical representative. (NCT01903031)
Timeframe: From day 0 to day 28
| Intervention | Percent of Participants (Number) |
|---|
| NuvaRing and no ART | 7.4 |
| NuvaRing With EFV Plus ≥2 NRTIs | 3.6 |
| NuvaRing With ATV/r Plus TDF and ≥1 NRTIs | 3.6 |
ATV PK Parameter AUC(0-24h) Calculated Based on Intensive Atazanavir (ATV) PK Samples Obtained From Individual Participants Enrolled in Arm C
This evaluates the effect of NuvaRing on the PK parameter AUC(0-24h) of ATV before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. AUC(0-24h) defines area under the concentration-time curve over the period of 24 hours (pre-dose concentration was used to impute concentration at 24h). (NCT01903031)
Timeframe: Intensive ATV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement)
| Intervention | h*ng/mL (Median) |
|---|
| AUC0-24h day 0 | AUC0-24h day 21 |
|---|
| NuvaRing With ATV/r Plus TDF and ≥1 NRTIs | 44313.7 | 36764.7 |
ATV PK Parameter CLss/F Determined Based on ATV Levels From Individual Participants Enrolled in Arm C
This evaluates the effect of NuvaRing on the ATV PK parameter CLss/F obtained from both sampling periods, before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. CLss/f defines apparent oral clearance. (NCT01903031)
Timeframe: Intensive ATV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).
| Intervention | L/h (Median) |
|---|
| CLss/F day 0 | CLss/F day 21 |
|---|
| NuvaRing With ATV/r Plus TDF ≥1 NRTIs | 6.8 | 8.2 |
ATV PK Parameter Cmax Determined Based on ATV Levels From Individual Participants Enrolled in Arm C
This evaluates the effect of NuvaRing on the ATV PK parameter Cmax obtained from both sampling periods, before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Cmax defines maximum concentration observed within the first 8 hours of the 24 hour dosing interval. (NCT01903031)
Timeframe: Intensive ATV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).
| Intervention | ng/mL (Median) |
|---|
| Cmax day 0 | Cmax day 21 |
|---|
| NuvaRing With ATV/r Plus TDF ≥1 NRTIs | 4291.0 | 3583.0 |
ATV PK Parameter Cmin Determined Based on ATV Levels From Individual Participants Enrolled in Arm C
This evaluates the effect of NuvaRing on the ATV PK parameter Cmin obtained from both sampling periods, before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Cmin defines minimum concentration observed within the first 8 hours of the 24 hour dosing interval. (NCT01903031)
Timeframe: Intensive ATV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).
| Intervention | ng/mL (Median) |
|---|
| Cmin day 0 | Cmin day 21 |
|---|
| NuvaRing With ATV/r Plus TDF ≥1 NRTIs | 796.7 | 599.4 |
ATV PK Parameter Time to Cmax (Tmax) Determined Based on ATV Levels From Individual Participants Enrolled in Arm C
This evaluates the effect of NuvaRing on the ATV PK parameter Tmax obtained from both sampling periods, before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Tmax defines time to maximum concentration since dose is initiated. (NCT01903031)
Timeframe: Intensive ATV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).
| Intervention | hour (Median) |
|---|
| Tmax day 0 | Tmax day 21 |
|---|
| NuvaRing With ATV/r Plus TDF ≥1 NRTIs | 2.9 | 3.0 |
EFV PK Parameter Area Under the Concentration-Time Curve (AUC0-24hours) Calculated Based on Intensive EFV PK Samples Obtained From Individual Participants Enrolled in Arm B
This evaluates the effect of NuvaRing on the PK parameter AUC(0-24h) of EFV before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. AUC(0-24h) defines area under the concentration-time curve over the period of 24 hours (pre-dose concentration was used to impute concentration at 24h). (NCT01903031)
Timeframe: Intensive EFV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).
| Intervention | h*ng/mL (Median) |
|---|
| AUC0-24h day 0 | AUC0-24h day 21 |
|---|
| NuvaRing With EFV Plus ≥2 NRTIs | 68949.1 | 57795.9 |
EFV PK Parameter Clearance (CLss/F) Determined Based on EFV Levels From Individual Participants Enrolled in Arm B
This evaluates the effect of NuvaRing on the EFV PK parameter CLss/F obtained from both sampling periods, before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. CLss/F defines apparent oral clearance (NCT01903031)
Timeframe: Intensive EFV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).
| Intervention | L/h (Median) |
|---|
| CLss/F day 0 | CLss/F day 21 |
|---|
| NuvaRing With EFV Plus ≥2 NRTIs | 8.7 | 10.4 |
EFV PK Parameter Maximum Plasma Concentration (Cmax) Determined Based on EFV Levels From Individual Participants Enrolled in Arm B
This evaluates the effect of NuvaRing on the EFV PK parameter Cmax obtained from both sampling periods, before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Cmax defines maximum concentration observed within the first 8 hours of the 24 hour dosing interval. (NCT01903031)
Timeframe: Intensive EFV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).
| Intervention | ng/mL (Median) |
|---|
| Cmax day 0 | Cmax day 21 |
|---|
| NuvaRing With EFV Plus ≥2 NRTIs | 4541.0 | 3786.0 |
EFV PK Parameter Minimum Plasma Concentration (Cmin) Determined Based on EFV Levels From Individual Participants Enrolled in Arm B
This evaluates the effect of NuvaRing on the EFV PK parameter Cmin obtained from both sampling periods, before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Cmin defines minimum concentration observed within the first 8 hours of the 24 hour dosing interval. (NCT01903031)
Timeframe: Intensive EFV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).
| Intervention | ng/mL (Median) |
|---|
| Cmin day 0 | Cmin day 21 |
|---|
| NuvaRing With EFV Plus ≥2 NRTIs | 2121.5 | 1766.0 |
Ethinyl Estradiol Concentrations Obtained on Study Days 7 and 14.
This evaluates the effect of EFV and ATV/r on ethinyl estradiol by measuring ethinyl estradiol concentrations on all three study arms 7 and 14 days after NuvaRing administration. The assay lower limit of quantification for ethinyl estradiol was 5 pg/mL; values < 5 were assigned a value of half the lower limit (ie, 2.5 pg/mL). (NCT01903031)
Timeframe: Study days 7 and 14
| Intervention | pg/mL (Median) |
|---|
| Concentration at Day 7 | Concentration at Day 14 |
|---|
| NuvaRing and no ART | 18.05 | 19.70 |
,| NuvaRing With ATV/r Plus TDF and ≥1 NRTIs | 15.70 | 16.55 |
,| NuvaRing With EFV Plus ≥2 NRTIs | 9.98 | 10.50 |
Etonogestrel Concentrations Obtained on Study Days 7 and 14
This evaluates the effect of EFV and ATV/r on etonogestrel by measuring etonogestrel concentrations on all three study arms 7 and 14 days after NuvaRing administration. The assay lower limit of quantification for etonogestrel was 250 pg/mL; values < 250 were assigned a value of half the lower limit (ie, 125 pg/mL). (NCT01903031)
Timeframe: Study days 7 and 14
| Intervention | pg/mL (Median) |
|---|
| Concentration at Day 7 | Concentration at Day 14 |
|---|
| NuvaRing and no ART | 1970.00 | 2070.00 |
,| NuvaRing With ATV/r Plus TDF and ≥1 NRTIs | 3250.00 | 3530.00 |
,| NuvaRing With EFV Plus ≥2 NRTIs | 427.00 | 437.00 |
Proportion of Participants With Plasma HIV-1 RNA Levels <40 Copies/mL
This evaluates the short-term impact of Nuvaring on virologic suppression in participants who have been administered Nuvaring alone or together with EFV or ATV/r by measuring proportion of participants with plasma HIV-1 RNA levels <40 copies/mL at study day 0 (before vaginal ring placement) and study day 21 (three weeks after vaginal ring placement). An FDA-approved HIV-1 RNA assay was required. (NCT01903031)
Timeframe: Study day 0 and study day 21
| Intervention | proportion of participants (Number) |
|---|
| Proportion with HIV-1 RNA <40 copies/mL at day 0 | Proportion with HIV-1 RNA <40 copies/mL at day 21 |
|---|
| NuvaRing and no ART | 0.22 | 0.17 |
,| NuvaRing With ATV/r Plus TDF and ≥1 NRTIs | 0.89 | 0.85 |
,| NuvaRing With EFV Plus ≥2 NRTIs | 0.93 | 0.85 |
Proportion of Participants With Progesterone Levels Greater Than 5 ng/mL.
This evaluates alterations in progesterone levels due to the potential PK interaction between NuvaRing and the ARVs EFV and ATV/r by examining progesterone levels at study days 0 (before vaginal ring placement), 7, 14, and 21 (before vaginal ring removal), and study day 28, without regard to menstrual cycle status at study entry. (NCT01903031)
Timeframe: Study days 0, 7, 14, 21 and 28
| Intervention | proportion of participants (Number) |
|---|
| Proportion with progesterone >5 at day 0 | Proportion with progesterone >5 at day 7 | Proportion with progesterone >5 at day 14 | Proportion with progesterone >5 at day 21 | Proportion with progesterone >5 at day 28 |
|---|
| NuvaRing and no ART | 0.08 | 0.08 | 0.00 | 0.00 | 0.00 |
,| NuvaRing With ATV/r Plus TDF and ≥1 NRTIs | 0.25 | 0.08 | 0.00 | 0.00 | 0.00 |
,| NuvaRing With EFV Plus ≥2 NRTIs | 0.04 | 0.24 | 0.04 | 0.00 | 0.00 |
Ritonavir (RTV) PK Parameter AUC(0-24h) Calculated Based on Intensive RTV PK Samples Obtained From Individual Participants Enrolled in Arm C
This evaluates the effect of NuvaRing on the PK parameter AUC(0-24h) of RTV before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. AUC(0-24h) defines area under the concentration-time curve over the period of 24 hours (pre-dose concentration was used to impute concentration at 24h). (NCT01903031)
Timeframe: Intensive RTV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement)
| Intervention | h*ng/mL (Median) |
|---|
| AUC0-24h day 0 | AUC0-24h day 21 |
|---|
| NuvaRing With ATV/r Plus TDF and ≥1 NRTIs | 10740.0 | 7210.7 |
RTV PK Parameter CLss/F Determined Based on RTV Levels From Individual Participants Enrolled in Arm C
This evaluates the effect of NuvaRing on the PK parameter CLss/F of RTV before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. CLss/F defines apparent oral clearance. (NCT01903031)
Timeframe: Intensive RTV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement)
| Intervention | hour (Median) |
|---|
| CLss/F day 0 | CLss/F day 21 |
|---|
| NuvaRing With ATV/r Plus TDF and ≥1 NRTIs | 9.3 | 13.9 |
RTV PK Parameter Cmax Determined Based on RTV Levels From Individual Participants Enrolled in Arm C
This evaluates the effect of NuvaRing on the PK parameter Cmax of RTV before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Cmax defines maximum concentration observed within the first 8 hours of the 24 hour dosing interval. (NCT01903031)
Timeframe: Intensive RTV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement)
| Intervention | ng/mL (Median) |
|---|
| Cmax day 0 | Cmax day 21 |
|---|
| NuvaRing With ATV/r Plus TDF and ≥1 NRTIs | 1437.0 | 1063.0 |
RTV PK Parameter Cmin Determined Based on RTV Levels From Individual Participants Enrolled in Arm C
This evaluates the effect of NuvaRing on the PK parameter Cmin of RTV before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Cmin defines minimum concentration observed within the first 8 hours of the 24 hour dosing interval. (NCT01903031)
Timeframe: Intensive RTV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement)
| Intervention | ng/mL (Median) |
|---|
| Cmin day 0 | Cmin day 21 |
|---|
| NuvaRing With ATV/r Plus TDF and ≥1 NRTIs | 70.0 | 51.9 |
RTV PK Parameter Tmax Determined Based on RTV Levels From Individual Participants Enrolled in Arm C
This evaluates the effect of NuvaRing on the PK parameter Tmax of RTV before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Tmax defines time to maximum concentration since dose is initiated. (NCT01903031)
Timeframe: Intensive RTV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement)
| Intervention | hour (Median) |
|---|
| Tmax day 0 | Tmax day 21 |
|---|
| NuvaRing With ATV/r Plus TDF and ≥1 NRTIs | 3.0 | 3.0 |
Other Studies
1 other study available for lynestrenol and HIV Coinfection