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

NCT00514098 | Completed

• 3 other identifiers: MTN-0155UM1AI06863310529
• Study Type: observational
• Target: 479
• Locations: 4 countries
• Sites: 17

Brief Summary

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.

Conditions

HIV Infections

Keywords

Microbicide; Seroconversion; Treatment Experienced; Treatment Naive

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• HIV disease progression comparison

  Total duration of follow up

• Virologic and immunologic response comparison

  Total duration of follow up

• HIV-1 drug resistance profile comparison

  Total duration of follow up

• Sexual behavior and partnership status changes

  Total duration of follow up

Other Outcomes (1)

• HIV-1 drug resistance mutation evaluation

  Total duration of follow up

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Microbicide Trials Network: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (18)

College of Med. JHU CRS

Blantyre, Malawi

Location

University of North Carolina Lilongwe

Lilongwe, Malawi

Location

Wits Reproductive Health Institute (WRHI)

Johannesburg, Gauteng, 2001, South Africa

Location

CAPRISA- The Aurum Institute

Johannesburg, Guateng, 2571, South Africa

Location

Botha's Hill CRS

Durban, KwaZulu-Natal, 3660, South Africa

Location

CAPRISA eThewkini

Durban, KwaZulu-Natal, 4001, South Africa

Location

Overport CRS

Durban, KwaZulu-Natal, 4091, South Africa

Location

Isipingo CRS

Durban, KwaZulu-Natal, 4133, South Africa

Location

Verulam CRS

Durban, KwaZulu-Natal, 4390, South Africa

Location

South African Medical Research Council, Tongaat

Durban, KwaZulu-Natal, South Africa

Location

Umkomaas CRS

Durban, KwaZulu-Natal, South Africa

Location

Perinatal HIV Research Unit (HPRU)

Johannesburg, Soweto, 1804, South Africa

Location

R. K. Khan CRS

Durban, South Africa

Location

Makerere University- JHU Research Collaboration {MUJHU CARE LTD} CRS

Kampala, Uganda

Location

Kamwala Clinic CRS

Kamwala, Zambia

Location

UZ-UCSF HIV Prevention Trials Unit

Harare, Chitungwiza, Zimbabwe

Location

Seke South CRS

Chitungwiza, Zimbabwe

Location

Spilhaus CRS

Harare, Zimbabwe

Location

Related Publications (3)

• 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.

  PMID: 30346511 RESULT

• 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.

  PMID: 28658251 RESULT

• 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.

  PMID: 27465646 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood and urine collection, pelvic, vaginal, and cervicovaginal sampling

MeSH Terms

Conditions

HIV Infections; HIV Seropositivity

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Sharon A. Riddler, MD

  University of Pittsburgh

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2007
• First Posted: August 9, 2007
• Study Start: August 25, 2008
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: June 21, 2021

Record last verified: 2021-06

Locations

ZA (11); MA (2); ZI (3); UG (1)