Correlated Drug Terms (1)

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	Name (Synonyms)	Correlation
drug2319	Standard of Care Wiki	0.20

Correlated MeSH Terms (1)

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	Name (Synonyms)	Correlation
D015658	HIV Infections NIH	0.41

Correlated HPO Terms (0)

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	Name (Synonyms)	Correlation

Primary Outcomes

Description: Participants with HIV-1 RNA < 50 copies/mL within the week 12 window (+/- 14 days) are classified as successes. Participants with HIV-1 RNA >= 50 copies/ml or with no HIV-1 RNA measurement within the week 12 window are classified as failures.

Measure: Proportion of participants with plasma Human Immunodeficiency Virus - Type I ribonucleic acid (HIV-1 RNA) levels less than (<) 50 copies/mL at week 12

Time: 12 weeks post enrollment

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Description: Participants with HIV-1 RNA < 200 copies/mL within the week 12 window (+/- 14 days) are classified as successes. Participants with HIV-1 RNA >= 200 copies/ml or with no HIV-1 RNA measurement within the week 12 window are classified as failures.

Measure: Proportion of participants with HIV-1 RNA < 200 copies/mL at week 12

Time: 12 weeks post enrollment

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Secondary Outcomes

Description: Participants with HIV-1 RNA < 50 copies/mL within each week window (+/- 28 days) are classified as successes. Participants with HIV-1 RNA >= 50 copies/ml or with no HIV-1 RNA measurement within the week window are classified as failures.

Measure: Proportion of participants with HIV-1 RNA < 50 copies/mL at weeks 24, 36 and 48

Time: 24, 36 and 48 weeks post enrollment

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Description: Participants with HIV-1 RNA < 200 copies/mL within each week window (+/- 28 days) are classified as successes. Participants with HIV-1 RNA >= 200 copies/ml or with no HIV-1 RNA measurement within the week window are classified as failures.

Measure: Proportion of participants with HIV-1 RNA < 200 copies/mL at weeks 24, 36 and 48

Time: 24, 36 and 48 weeks post enrollment

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Description: Participants are classified as successes if both the week 12 (+/- 14 days) and week 48 (+/- 28 days) HIV-1 RNA measurements are < 200 copies/ml and at least one of the week 24 (+/- 28 days) or week 36 (+/- 28 days) HIV-1 RNA measurements is < 200 copies/ml. Otherwise the participant is classified as a failure.

Measure: Proportion of participants with HIV-1 RNA < 200 copies/mL at 12 weeks and maintained through 48 weeks

Time: 24, 36 and 48 weeks post enrollment

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Description: For each participant, the percentage of days in each 7-day period in which all doses were taken is calculated, and then averaged across the 12 week interval (or number of weeks with available data).

Measure: Percent of days with all doses taken per week from weeks 0-12, 12-24, 24-36 and 36-48

Time: Enrollment through 48 weeks

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Description: For each participant, the percentage of days in each 7-day period in which all doses were taken within the defined acceptable windows (within 4 hours for once/day ART and within 2 hours for twice/day ART) is calculated, and then averaged across the 12 week interval (or number of weeks with available data).

Measure: Percent of days with all doses taken within defined acceptable windows (within 4 hours for once/day ART and within 2 hours for twice/day ART) per week from weeks 0-12, 12-24, 24-36 and 36-48

Time: Enrollment through 48 weeks

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Description: For each participant, the incidence rate during each 12 week interval is calculated as the ratio of the number of gaps between doses of >7 consecutive days relative to the number of days with data reported, times 100. Consecutive gaps of more than 7 days increase the gap count by one, e.g. missing 20 days counts as 2 gaps.

Measure: Incidence rate (per 100 days) of gaps between dosing of at least 7 consecutive days between weeks 0-12, 12-24, 24-36 and 36-48

Time: Enrollment through 48 weeks

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