Trial · NCT00955968
Outcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence Rates of AIDS - Defining Illness, Serious Non-AIDS Defining, Cardiovascular, Renal, Hepatic Event, or Death | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). | All participants except one who was excluded as she withdrew from study on the day she was randomized | New cases per 100 person - years | NUMBER |
| SECONDARY | Incidence Rate of AIDS - Defining Illness | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). | All participants except one who was excluded as she withdrew from study on the day she was randomized | New cases per 100 person - years | NUMBER |
| SECONDARY | Incidence Rates of Serious Non- AIDS Defining Cardiovascular, Renal or Hepatic Event | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). | All participants except one who was excluded as she withdrew from study on the day she was randomized | New cases per 100 person - years | NUMBER |
| SECONDARY | Incidence Rate of Deaths | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). | All participants except one who was excluded as she withdrew from study on the day she was randomized | New cases per 100 person - years | NUMBER |
| SECONDARY | Incidence Rate of HIV/AIDS Related Events | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). | All participants except one who was excluded as she withdrew from study on the day she was randomized | New cases per 100 person - years | NUMBER |
| SECONDARY | Incidence Rate of HIV/AIDS Related Events or Death | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). | All participants except one who was excluded as she withdrew from study on the day she was randomized | New cases per 100 person - years | NUMBER |
| SECONDARY | Incidence Rate of HIV/AIDS Related Events or WHO Clinical Stage 2 or 3 Events | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). | All participants except one who was excluded as she withdrew from study on the day she was randomized | New cases per 100 person - years | NUMBER |
| SECONDARY | Incidence Rate of Grade 2 and Above Toxicity | All laboratory measures were done at entry,4 and 12 weeks after, and then every 3 months until study end. Signs and Symptoms were recorded from study entry to study end. All were followed until July 7, 2015 (an average of 125 weeks of follow-up) | All participants except one who was excluded as she withdrew from study on the day she was randomized | New cases per 100 person - years | NUMBER |
| SECONDARY | Incidence Rate of Cardiovascular or Other Metabolic Events | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). | This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. Given the results of the primary analyses it was decided that this outcome was no longer scientifically important. No resources and funding was allocated by NIH. | ||
| SECONDARY | Incidence Rate of Other Targeted Medical Conditions | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). | This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. Given the results of the primary analyses it was decided that this outcome was no longer scientifically important. No resources and funding was allocated by NIH. | ||
| SECONDARY | Incidence Rate of Any Condition Outlined in Appendix II of Protocol or Death | From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). | This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. Given the results of the primary analyses it was decided that this outcome was no longer scientifically important. No resources and funding was allocated by NIH. | ||
| SECONDARY | Number of Virologic Failure (VF) Participants With HIV Resistance in the Continue HAART Arm | At time of confirmation of VF. HIV-1 RNA testing to identify VF was done at week 4, 12, 24, and every 12 weeks thereafter until study end at an average of 125 weeks. If HIV-1 RNA was above 1000 copies/ml, confirmatory testing was done within 4 weeks. | 156 women who were VFs had antiretroviral drug resistance testing performed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Medication Adherence - Last Time Missed Medications | week 0, 48 and 96 | Participants in the Continue HAART arm who had evaluations done at the respective weeks | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Medication Adherence - How Closely Followed Schedule | week 0, 48 and 96 | Participants in the Continue HAART arm who had evaluations done at the respective weeks | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Medication Adherence - How Often Follow Instructions | week 0, 48 and 96 | Participants in the Continue HAART arm who had evaluations done at the respective weeks | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Medication Adherence - Missed Dose Within Past 4 Days | week 0, 48 and 96 | Participants in the Continue HAART arm who had evaluations done at the respective weeks | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Quality of Life - General Health Outcome | week 0, 48 and 96 | All participants except one who was excluded as she withdrew from study on the day she was randomized | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Quality of Life (QoL) - Health Rating Score | week 0, 48 and 96 | All participants except one who was excluded as she withdrew from study on the day she was randomized | units on a scale | MEAN |
| SECONDARY | Changes in Plasma Concentrations of Inflammatory and Thrombogenic Markers | Measured at baseline, after 4 and 12 weeks, and then every 6 months until study termination. All participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). | This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. This outcome required additional funding for laboratory testing which was not available and so this outcome is not reported. | ||
| SECONDARY | Cost Effectiveness and Feasibility of Treatment Models | Measured at baseline, after 4 - 12 and 24 weeks, and then every 6 months until study termination. All participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). | This outcome was intended as an exploratory analyses and was not included in the primary analyses. Given the results of the primary analyses and changes in WHO guidelines to recommend lifelong antiretroviral therapy, the protocol team decided that this outcome was no longer scientifically important. No resources and funding was allocated by NIH. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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