Observational Study of HIV Infected Women Previously Enrolled in Other Microbicide Trials

An Observational Cohort Study of Women Following HIV-1 Seroconversion in Microbicide Trials

A new approach to HIV prevention currently being studied includes the use of topical microbicides and orally administered anti-HIV drugs. The purpose of this study is to better understand the impact of microbicides in women who are diagnosed with HIV-1 during participation in previous microbicide trials.

Study Overview

• Status: Completed
• Conditions: HIV Infections

Detailed Description

It is necessary to monitor HIV over long periods of time in order to better understand the impact of microbicides and anti-HIV drugs on the progression of HIV infection in those who become infected or are unknowingly already infected while receiving these drugs. The purpose of this study is to determine the effects of microbicides or oral anti-HIV drugs over time in HIV infected women who were previously enrolled in other microbicide trials.

The study will remain open to accrual for the duration of MTN funding, and will use two follow-up visit schedules, one based on the date of diagnosis in the parent study, and one based on the initiation of antiretroviral treatment (ART). Participants who have not initiated ART at the time of enrollment in this study will follow the schedule based on the date of diagnosis. Participants who have already begun ART at the time of enrollment will follow the schedule based on the date of ART initiation. Individuals enrolled with a starting date based on the date of ART initiation will have their first follow-up visit at Week 2 before resuming the rest of the schedule. On both schedules, follow-up visits occur at Months 1, 3, and 6 and every 6 months thereafter. Interim visits may be performed at any time during follow-up, and participants will be asked to attend a final study visit prior to their termination from the study. Participants may enroll any time after their HIV diagnosis and can leave the study at any time.

A physical exam; medical and medication history assessment; blood and urine collection; and pelvic, cervicovaginal lavage, and vaginal swab sampling will occur at all visits. A behavioral assessment will occur at select visits, and adherence and social harms assessments will occur at most visits. Sexually transmitted infection risk reduction/contraception and HIV-1 secondary counseling will occur at most visits. In addition, condoms will be provided at all visits to reduce further HIV transmission. ART will not be provided by this study.

• Study Type: Observational
• Enrollment (Actual): 479

Contacts and Locations

Study Locations

• Malawi
  • Blantyre, Malawi
    • College of Med. JHU CRS
  • Lilongwe, Malawi
    • University of North Carolina Lilongwe
• South Africa
  • Durban, South Africa
    • R. K. Khan CRS
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 2001
      • Wits Reproductive Health Institute (WRHI)
  • Guateng
    • Johannesburg, Guateng, South Africa, 2571
      • CAPRISA- The Aurum Institute
  • KwaZulu Natal
    • Durban, KwaZulu Natal, South Africa, 4001
      • CAPRISA eThewkini
    • Durban, KwaZulu Natal, South Africa
      • South African Medical Research Council, Tongaat
  • KwaZulu-Natal
    • Durban, KwaZulu-Natal, South Africa, 4133
      • Isipingo CRS
    • Durban, KwaZulu-Natal, South Africa
      • Umkomaas CRS
    • Durban, KwaZulu-Natal, South Africa, 3660
      • Botha's Hill CRS
    • Durban, KwaZulu-Natal, South Africa, 4091
      • Overport CRS
    • Durban, KwaZulu-Natal, South Africa, 4390
      • Verulam CRS
  • Soweto
    • Johannesburg, Soweto, South Africa, 1804
      • Perinatal HIV Research Unit (HPRU)
• Uganda
  • Kampala, Uganda
    • Makerere University- JHU Research Collaboration {MUJHU CARE LTD} CRS
• Zambia
  • Kamwala, Zambia
    • Kamwala Clinic CRS
• Zimbabwe
  • Chitungwiza, Zimbabwe
    • Seke South CRS
  • Harare, Zimbabwe
    • Spilhaus CRS
  • Chitungwiza
    • Harare, Chitungwiza, Zimbabwe
      • UZ-UCSF HIV Prevention Trials Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Women who are diagnosed with HIV-1 during participation in previous microbicide trials

Description

Inclusion Criteria:

• Diagnosis of HIV-1 infection during participation in any Microbicide Trials Network (MTN) clinical trial (including HPTN 035 and HPTN 059), according to the HIV testing algorithm of the parent MTN trial
• Parent or guardian willing to provide informed consent, if applicable

Exclusion Criteria:

• Any condition that, in the opinion of the investigator, makes participation in the study unsafe or interferes with the study

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV disease progression comparison	To compare HIV disease progression 12 months post seroconversion among participants assigned to an active agent compared to placebo/control participants.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV disease progression comparison	To compare virologic and immunologic responses following initiation of antiretroviral therapy among participants assigned to an active agent versus placebo/control participants.	Total duration of follow up
Virologic and immunologic response comparison	To compare virologic and immunologic responses following initiation of antiretroviral therapy among participants assigned to an active agent versus placebo/control participants.	Total duration of follow up
HIV-1 drug resistance profile comparison	To compare the HIV-1 drug resistance profile, among antiretroviral therapy recipients at the time of virologic failure in participants assigned to an active agent versus placebo/control participants.	Total duration of follow up
Sexual behavior and partnership status changes	To describe post seroconversion changes in sexual behaviors and partnership status of participants.	Total duration of follow up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV-1 drug resistance mutation evaluation	To evaluate the prevalence and persistence of HIV-1 drug resistance mutations in plasma and/or genital tract specimens after HIV-1 seroconversion using both standard and sensitive methods in specific subgroups of seroconverters.	Total duration of follow up

Collaborators and Investigators

• Sponsor: Microbicide Trials Network
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institute of Mental Health (NIMH)
• Investigators: Study Chair: Sharon A. Riddler, MD, University of Pittsburgh

Publications and helpful links

General Publications

• Riddler SA, Balkus JE, Parikh UM, Mellors JW, Akello C, Dadabhai S, Mhlanga F, Ramjee G, Mayo AJ, Livant E, Heaps AL, O'Rourke C, Baeten JM; MTN-015 and MTN-020/ASPIRE Study Teams. Clinical and Virologic Outcomes Following Initiation of Antiretroviral Therapy Among Seroconverters in the Microbicide Trials Network-020 Phase III Trial of the Dapivirine Vaginal Ring. Clin Infect Dis. 2019 Jul 18;69(3):523-529. doi: 10.1093/cid/ciy909.
• Riddler SA, Husnik M, Ramjee G, Premrajh A, Tutshana BO, Pather A, Siva S, Jeenarain N, Nair G, Selepe P, Kabwigu S, Palanee-Phillips T, Panchia R, Mhlanga F, Levy L, Livant E, Patterson K, Elharrar V, Balkus J. HIV disease progression among women following seroconversion during a tenofovir-based HIV prevention trial. PLoS One. 2017 Jun 28;12(6):e0178594. doi: 10.1371/journal.pone.0178594. eCollection 2017.
• Riddler SA, Husnik M, Gorbach PM, Levy L, Parikh U, Livant E, Pather A, Makanani B, Muhlanga F, Kasaro M, Martinson F, Elharrar V, Balkus JE; MTN-015 Protocol Team for the Microbicide Trials Network. Long-term follow-up of HIV seroconverters in microbicide trials - rationale, study design, and challenges in MTN-015. HIV Clin Trials. 2016 Sep;17(5):204-11. doi: 10.1080/15284336.2016.1212561. Epub 2016 Jul 28.

Helpful Links

• Click here for the Microbicide Trials Network Web site

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2008
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: August 8, 2007
• First Submitted That Met QC Criteria: August 8, 2007
• First Posted (Estimate): August 9, 2007

Study Record Updates

• Last Update Posted (Actual): June 21, 2021
• Last Update Submitted That Met QC Criteria: June 17, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Treatment Experienced; Treatment Naive; Microbicide; Seroconversion
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: MTN-015; 5UM1AI068633 (U.S. NIH Grant/Contract); 10529 (Registry Identifier: DAIDS ES Registry Number)